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Federal Government Programs. Patient Safety. Informed Consent. Tumor regression score Grade 0 and 1 will be defined as "responder" and 2 and 3 will be considered as "non-responders" Incidence of adverse events [ Time Frame: 6 months ] Number of participants with treatment-related adverse events as assessed by Number of participants with treatment-related adverse events as assessed by treatment-related adverse events assessed by CTCAE v4.
Rate of R0 resection [ Time Frame: 3 months ] Measure the rate of R0 resection with all margins microscopically clear. Participants who did not experience a non-fatal event as of the time of data cut-off end of study , as well as participants who did not experience a non-fatal event and stopped study participation before the data cut-off, were censored as specified in the protocol. Overall Survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to months.
Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Try the modernized ClinicalTrials. Learn more about the modernization effort. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Last Update Posted : January 12, See Contacts and Locations. Study Description. Tislelizumab combined with chemotherapy sequential neoadjuvant therapy for non-cCR patients after neoadjuvant chemoradiotherapy in locally advanced ESCC.
I am looking for doxorubicin. I am looking for fluorouracil. I am looking for leucovorin. I am looking for prednisone. I am looking for cyclophosphamide. I am looking for gemcitabine. I am looking for tyrosine. I am looking for cetuximab.
I am looking for irinotecan. I am looking for hormone therapy. I am looking for epirubicin. I am looking for capecitabine. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving temozolomide and cixutumumab together with The purpose of this study is to evaluate the efficacy and safety of ruxolitinib versus anagrelide in subjects with essential thrombocythemia who are resistant to or intolerant of hydroxyurea.
Carboplatin-Paclitaxel with placebo in participants with inoperable, locally-advanced or metastatic Squamous Cell Anal Carcinoma SCAC not previously treated with systemic chemotherapy. The focus of this study is to evaluate the efficacy, safety, and tolerability of veliparib in women with previously untreated, Stage III or IV, high-grade serous, epithelial ovarian, fallopian tube, or primary peritoneal cancer. The purpose of trhis study is to evaluate CPI in patients who have both received JAK inhibitors, such as ruxolitinib Arms 1 and 2 , and in patients who have never been treated with a JAK inhibitor Arm 3.
This randomized phase II trial studies the side effects and how well carboplatin and gemcitabine hydrochloride with or without ATR kinase inhibitor VX work in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back recurrent and has spread to other places in the body metastatic. Drugs used in chemotherapy, such as carboplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
ATR kinase inhibitor VX may stop the growth of tumor cells by blocking The purpose of this study is to determine a recommended phase 2 dose RP2D of pevonedistat, azacitidine or decitabine , and venetoclax to treat Acute Myelogenous Leukemia.
This randomized pilot clinical trial studies topical cryotherapy a procedure in which an extremely cold liquid is used to freeze and destroy abnormal tissue in reducing pain in patients with chemotherapy induced peripheral neuropathy or paclitaxel induced acute pain syndrome.
Peripheral neuropathy is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. Paclitaxel produces a disabling syndrome of acute aches and pains. Topical cryotherapy may help relieve pain from peripheral neuropathy or acute pain syndrome caused by chemotherapy. The purpose of this study is to establish the recommended phase 2 dose RP2D of niraparib combination therapies of Part 1 and to evaluate the antitumor activity and safety of niraparib combination therapies of Part 2.
This is a Phase 2, single-arm, open-label, multicenter study evaluating efficacy, safety and tolerability of navitoclax added to ruxolitinib in participants with myelofibrosis. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit.
The purpose of this study is to compare the effects, both good This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. Trastuzumab emtansine T-DM The purpose of this study is to evaluate different strategies of cardiovascular therapy with carvedilol aiming to reduce the incidence of heart function declines and heart failure in at-risk breast cancer patients while on trastuzumab therapy.
The purpose of this study is to determine whether a supervised exercise-training program, initiated prior to chemotherapy induction pre-conditioning and continued throughout chemotherapy treatment, can preserve short- and long-term cardiovascular performance, skeletal muscle function, cognitive ability and quality of life better than current standard or care recommendations for exercise during chemotherapy.
The purpose of the study is to alleviate the occurrence of chemotherapy-induced nausea CIN and to improve chemotherapy treatment outcomes. Recent research has shown that changes in the functions performed by the gut microbiome can cause the occurrence of chemotherapy-induced symptoms that include chemotherapy-induced nausea. The study is designed as an open-label, randomized, parallel, two arm, multicenter, international Phase 3 study in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens.
The primary study objective is to compare overall survival of patients who receive NKTR given once every 21 days to patients who receive treatment of Physician's Choice selected from a list of seven single-agent intravenous therapies.
The purpose of this study is to continue with a long term follow-up of previously enrolled people treated with doxorubicin-cyclophosphamid followed by paclitaxel or docetaxel for axillary node-positive or high risk node-negative breast cancer. RATIONALE: Giving calcium together with magnesium may stop or delay the development of peripheral neuropathy in patients with cancer who are receiving treatment with ixabepilone.
It is not yet known whether calcium and magnesium are more effective than a placebo in preventing peripheral neuropathy caused by ixabepilone. PURPOSE: This randomized phase III trial is studying calcium given together with magnesium to see how well it works compared with a placebo in preventing peripheral neuropathy caused by ixabepilone in patients with breast cancer.
The purpose of this study is to collect clinical and biomarker data from patients receiving neurotoxic chemotherapy who are at risk for developing Chemotherapy-induced Peripheral Neuropathy CIPN. The purpose of this study is to assess genetic predictors of chemotherapy-related amenorrhea in breast cancer survivors of both European and non-European ancestry. It is not yet known which combination chemotherapy regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating women with breast cancer who have undergone surgery to remove the tumor.
Giving the drugs in different combinations may kill more breast cancer cells. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating women with non-metastatic breast cancer.
This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus Herceptin t rastuzumab as adjuvant therapy in patients with operable HER2-positive primary breast cancer.
After surgery, patients will be randomized to receive either pertuzumab or placebo intravenously iv every 3 weeks for one year, in addition to cycles of chemotherapy and 1 year of Herceptin trastuzumab iv every 3 wee ks. Anticipated time on study treatment is 52 weeks. This phase II trial studies how well FASN inhibitor TVB and trastuzumab plus either paclitaxel or endocrine therapy with an aromatase inhibitor work in treating patients with HER2 positive breast cancer that has spread to other places in the body.
Drugs used in chemotherapy, such as paclitaxel and trastuzumab, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Endcocrine therapy helps reduce The primary objective of this study is to compare progression-free survival PFS in patients with advanced HER2-positive breast cancer treated with T-DM1 and abemaciclib vs. T-DM1 monotherapy. The purpose of this study is to test the safety of an investigational drug called LB for Injection for treatment of solid tumors, when given with or without docetaxel.
LB is a small molecule that in laboratory and animal studies has shown activity when used by itself or together with drugs approved to treat some types of cancer chemotherapeutic agents. The study is in 2 parts. Part 1: Patients will receive injections of LB This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome.
Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment Induction I. Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the Giving radiation therapy together with temozolomide may kill more tumor cells.
The purpose of this study is to demonstrate the benefit of Panzyga administration compared with placebo as primary infection prophylaxis in Chronic Lymphocytic Leukemia CLL patients with secondary immunodeficiency SID undergoing CLL antineoplastic therapy. The purpose of this study is to determine the percentage of patients receiving cancer-directed therapy at the Gonda 10 chemotherapy unit who have had or are currently experiencing symptoms of nasal vestibulitis.
Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide together with ixazomib and dexamethasone may be an effective treatment for multiple myeloma. The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves overall response rate ORR by Cycle 6 and whether the combination of pevonedistat and azacitidine improves event-free survival EFS when compared with single-agent azacitidine.
The hypothesis of our pilot study is that patients receiving cryotherapy during infusion of taxane therapy will have lower incidence of peripheral neuropathy, better physical function, and higher quality of life as compared to patients previously reported in literature.
The purpose of this study is to determine the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness peripheral neuropathy caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer. Duloxetine increases the amount of certain chemicals in the brain that help relieve depression and pain. Giving duloxetine in patients undergoing treatment with oxaliplatin for colorectal cancer may help prevent peripheral neuropathy.
The purpose of this study is to evaluate how well trabectedin and olaparib work in treating patients with sarcoma that cannot be removed by surgery or has spread to other places in the body. Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing cells, stopping them from dividing or stopping them from spreading.
Olaparib may stop the growth of tumor cells by blocking pathways responsible for repairing damaged cells. Giving trabectedin and olaparib may shrink or stop the tumor from growing.
This is a Phase 1, open-label, multicenter, randomized, 2-stage crossover study consisting of 2 phases: Stage I - Pharmacokinetics Bioequivalence , with an Extension Stage II - Pharmacokinetics Food Effect with an Extension This study will enroll approximately 60 subjects in stage I and 60 subjects in stage II with hematologic or solid tumor malignancies, excluding gastrointestinal tumors and tumors that have originated or metastasized to the liver for which no standard treatment exists or have progressed or recurred following prior therapy.
Subjects must not be eligible for therapy of higher curative potential where an alternative treatment has been shown to The goal of this clinical research study is to learn if adding abraxane nab-paclitaxel to gemcitabine and cisplatin can help to control metastatic or unresectable biliary cancer.
The safety of this drug combination will also be studied. Among persons with Immunoglobulin G subclass 4 Related Disease IgG4 -related disease who have persistent or recurrent disease despite standard therapies, does combination therapy with rituximab and revlimid cause a sustained disease remission?
The main purpose of this study is to evaluate the efficacy of the combination of doxorubicin plus the study drug known as olaratumab versus doxorubicin plus placebo in participants with advanced or metastatic soft tissue sarcoma. Participants will be randomized to receive either MMB or ruxolitinib for 24 weeks during a double-blind treatment phase, after which they will be eligible to receive open-label MMB for up to an additional weeks.
After discontinuation of study medication, assessments will continue for 12 additional weeks, after which participants will be contacted for survival follow-up approximately every 6 months The purpose of this study is to evaluate how well daunorubicin and cytarabine, with or without uproleselan, works in treating older adult patients with acute myeloid leukemia receiving intensive induction chemotherapy. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Uproleselan may prevent cancer from returning or getting worse. Giving daunorubicin and cytarabine with uproleselan may work better in treating patients with acute myeloid leukemia compared to daunorubicin and cytarabine alone. The purpose of this study is to examine how well ascorbic acid and combination chemotherapy work in treating patients with lymphoma that has come back or does not respond to therapy.
Ascorbic acid may make cancer cells more sensitive to chemotherapy. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ascorbic acid and combination chemotherapy may work better at treating lymphoma. This phase II pilot trial studies how well ruxolitinib phosphate and danazol work in treating anemia in patients with myelofibrosis.
Ruxolitinib phosphate and danazol may cause the body to make more red blood cells. They are used to treat anemia in patients with myelofibrosis. The purpose of this study is to evaluate the safety and tolerability of the combination of DSa in combination with olaparib, and to determine the recommended phase 2 dose RP2D 1.
The purpose of this study is to evaluate an investigational drug as a possible treatment for breast cancer that is positive for the protein Human Epidermal Growth Factor Receptor 2, also known as HER2-positive breast cancer. The drug involved in this study is: -ado-trastuzumab emtansine T-DM1. This randomized phase III trial studies combination chemotherapy and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer.
It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer. Chemoprotective drugs, such as glutathione, may help prevent peripheral neuropathy caused by paclitaxel and carboplatin. It is not yet known whether glutathione is more effective than a placebo in preventing peripheral neuropathy.
The purpose of this study is to confirm that adding custirsen to standard first-line docetaxel and prednisone treatment can slow tumor progression in men who have prostate cancer, and enhance survival outcomes compared to standard first-line docetaxel and prednisone treatment alone. This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety of orally administered ABT combined with decitabine or azacitidine and the preliminary efficacy of one of these combinations.
In addition, there is a DDI sub-study only at a single site, to assess the pharmacokinetics and safety of ABT in combination with posaconazole. This phase II trial studies how well pomalidomide, ixazomib citrate, and dexamethasone work in treating patients with previously treated multiple myeloma or plasma cell leukemia.
Biological therapies, such as pomalidomide, and dexamethasone, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pomalidomide, ixazomib citrate, and dexamethasone together may be more effective in treating multiple myeloma.
This randomized phase III trial was originally designed to compare three different combination chemotherapy regimens to see how well they work. As of September 1, , the study was expanded to a total of 6 arms the original 3 arms A, B, C and 3 additional arms which were the same as the first 3 but with cetuximab in treating patients who have undergone surgery for stage III colon cancer.
Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. The purpose of this study is to see how well cediranib maleate and olaparib work when given together or separately, and compares them to standard chemotherapy in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has returned after receiving chemotherapy with drugs that contain platinum platinum-resistant or continued to grow while being treated with platinum-based chemotherapy drugs platinum-refractory.
Cediranib maleate and olaparib may stop the growth of tumor cells by blocking enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping This clinical study is in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer.
The study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of treatment. Subjects who complete the treatment will choose, with their treating physicians, what additional treatment should be given: more nab-Paclitaxel plus gemcitabine, Chemoradiation therapy, or surgery to treat the locally advanced pancreatic cancer. This randomized phase II trial studies how well obinutuzumab with or without PI3K-delta inhibitor TGR, lenalidomide, or combination chemotherapy work in treating patients with grade I-IIIa follicular lymphoma that has come back or does not respond to treatment.
Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread.
PI3K-delta inhibitor TGR may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer The primary purpose of this study is to determine if bortezomib, daratumumab, lenalidomide and dexamethasone Btz-DRd consolidation followed by daratumumab and lenalidomide DR maintenance after standard induction therapy with daratumumab, lenalidomide and dexamethasone DRd results in superior overall survival compared to DRd consolidation followed by DR maintenance, in MRD positive patients.
The purpose of this study is to evaluate treatment-emergent nasal vestibulitis symptoms in patients undergoing systemic antineoplastic therapy. After completion of PK studies during the first 2 treatment cycles, subjects will continue to receive treatment with ASTX from Cycle 3 onward in day cycles until disease progression, unacceptable toxicity, or the subject discontinues treatment or withdraws from the study.
The purpose of this study is to evaluate the safety and effectiveness of AL catequentibub, anlotinib hydrochloride in the treatment of metastatic or advanced alveolar soft part sarcoma ASPS , leiomyosarcoma LMS , and synovial sarcoma SS. Two-thirds of the participants will receive AL, one-third of the participants will receive IV dacarbazine.
The purpose of this study is to evaluate the additional benefit of pravastatin and spironolactone when given in combination with carvedilol and lisinopril versus carvedilol and lisinopril alone. Primary Objective: To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose dexamethasone in the prolongation of Progression Free Survival PFS as compared to pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma MM.
This randomized phase II trial studies how well irinotecan hydrochloride and cetuximab with or without vemurafenib works in treating patients with colorectal cancer that has spread to nearby tissue or lymph nodes, that has spread to other places in the body, or cannot be removed by surgery.
Irinotecan hydrochloride and vemurafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may block the ability of tumor cells to grow and spread. It is not yet known whether irinotecan hydrochloride and cetuximab are more effective with or without The purpose of this study is to follow patients with malignant mesothelioma of the lung after they have had combined chemotherapy, surgery, and intensity modified radiation therapy and determine response rates and overall survival.
The purpose of this study is to evaluate the investigational drug PledOx in the prevention of chronic chemotherapy induced peripheral neuropathy CIPN induced by the drug oxaliplatin.
This randomized pilot clinical trial studies the side effects and best dose of naloxegol and to see how well it works in treating patients with stage IIIB-IV non-small cell lung cancer. Naloxegol may relieve some of the side effects of opioid pain medication and fight off future growth in the cancer.
The purpose of this study is to compare the effectiveness of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis. The purpose of this study is to evaluate how well gemcitabine hydrochloride and cisplatin given with or without nab-paclitaxel work in treating patients with newly diagnosed biliary tract cancers that have spread to other places in the body.
Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not known if giving gemcitabine hydrochloride and cisplatin with or without nab-paclitaxel may work better at treating biliary tract cancers.
This phase II trial is studying giving veliparib together with carboplatin to see how well they work compared to veliparib alone in treating patients with stage III or stage IV breast cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether veliparib is more effective with or without carboplatin in treating breast cancer. This study is an open label, randomized, multicenter trial of MM plus trastuzumab. Patients may not have been previously treated with an anthracycline in any setting.
Patients must have received prior treatment with trastuzumab in any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the metastatic or locally advanced setting, have either progressed or are intolerant to pertuzumab in the metastatic or locally advanced setting or had disease This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor HER 2-low, hormone receptor HR positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.
The purpose of this study is to determine the correlation between HER2 specific T-cell response in HER2-positive breast cancer patients with stage I-IV who receive anti-HER2 therapies, such as trastuzumab, pertuzumab, lapatinib, or neratinib and clinical responses.
This phase I trial studies the side effects and best dose of olaparib and onalespib when given together in treating patients with solid tumors that have spread to other places in the body or cannot be removed by surgery or ovarian, fallopian tube, primary peritoneal, or triple-negative breast cancer that has come back. Olaparib and onalespib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Patients will be assessed for safety by regular evaluation of AEs, vital signs, routine clinical laboratory tests hematology, blood chemistry , LVEF assessments, and by physical examinations.
The purpose of this research study is to determine how well neratinib works in treating breast cancer that has spread to the brain. Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting or blocking members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 HER2.
In this research study, the investigators are looking to see how well neratinib works to decrease the size of or stabilize breast cancer that has spread to the brain. The investigators are also looking at how previous treatments have affected your Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
It is not yet known if cisplatin is more Selumetinib is a drug that works by blocking some enzymes that low grade glioma tumor cells need for their growth. This results in killing tumor cells.
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