Clinical Trials Using Temozolomide

Clinical trials are research studies that involve people. The clinical trials on this list are studying Temozolomide. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-25 of 84
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  • Cisplatin, Carboplatin and Etoposide or Temozolomide and Capecitabine in Treating Patients with Neuroendocrine Carcinoma of the Gastrointestinal Tract or Pancreas That Is Metastatic or Cannot Be Removed by Surgery

    This phase II trial studies how well temozolomide and capecitabine work compared to standard treatment with cisplatin or carboplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). Drugs used in chemotherapy, such as temozolomide, capecitabine, cisplatin, carboplatin and etoposide, 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. Certain types of neuroendocrine carcinomas may respond better to treatments other than the current standard treatment of cisplatin and etoposide. It is not yet known whether temozolomide and capecitabine may work better than cisplatin or carboplatin and etoposide in treating patients with this type of neuroendocrine carcinoma, called non-small cell neuroendocrine carcinoma.
    Location: 554 locations

  • Veliparib, Radiation Therapy, and Temozolomide in Treating Patients with Newly Diagnosed Malignant Glioma without H3 K27M or BRAFV600 Mutations

    This phase II trial studies how well veliparib, radiation therapy, and temozolomide work in treating patients with newly diagnosed malignant glioma without H3 K27M or BRAFV600 mutations. Poly adenosine diphosphate (ADP) ribose polymerases (PARPs) are proteins that help repair DNA mutations. PARP inhibitors, such as veliparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, 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. Giving veliparib, radiation therapy, and temozolomide may work better in treating patients with newly diagnosed malignant glioma without H3 K27M or BRAFV600 mutations compared to radiation therapy and temozolomide alone.
    Location: 141 locations

  • Irinotecan Hydrochloride, Temozolomide, and Dinutuximab with or without Eflornithine in Treating Patients with Relapsed or Refractory Neuroblastoma

    This phase II trial studies how well irinotecan hydrochloride, temozolomide, and dinutuximab work with or without eflornithine in treating patients with neuroblastoma that has come back (relapsed) or that isn't responding to treatment (refractory). Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, 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. Immunotherapy with monoclonal antibodies, such as dinutuximab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Eflornithine blocks the production of chemicals called polyamines that are important in the growth of cancer cells. Giving eflornithine with irinotecan hydrochloride, temozolomide, and dinutuximab, may work better in treating patients with relapsed or refractory neuroblastoma.
    Location: 119 locations

  • Testing the Use of the Immunotherapy Drugs Ipilimumab and Nivolumab plus Radiation Therapy Compared to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Unmethylated Glioblastoma

    This phase II / III trial compares the usual treatment with radiation therapy and temozolomide to radiation therapy in combination with immunotherapy with ipilimumab and nivolumab in treating patients with newly diagnosed MGMT unmethylated glioblastoma. Radiation therapy uses high energy photons to kill tumor and shrink tumors. Chemotherapy drugs, such as temozolomide, 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. Temozolomide, may not work as well for the treatment of tumors that have the unmethylated MGMT. Immunotherapy with monoclonal antibodies called immune checkpoint inhibitors, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is possible that immune checkpoint inhibitors may work better at time of first diagnosisd as opposed to when it comes back. Giving radiation therapy with ipilimumab and nivolumab may lengthen the time without brain tumor returning or growing and may extend patients’ life compared to usual treatment with radiation therapy and temozolomide.
    Location: 144 locations

  • Radiation Therapy or Radiation Therapy and Temozolomide in Treating Patients with Newly Diagnosed Anaplastic Glioma or Low Grade Glioma

    This randomized phase III trial compares giving radiation therapy alone or temozolomide together with radiation therapy and to see which works best in treating patients with newly diagnosed anaplastic glioma or low grade glioma. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, 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 whether giving radiation therapy alone or temozolomide together with radiation therapy is better in treating anaplastic glioma or low grade glioma.
    Location: 204 locations

  • Testing the Addition of an Anticancer Drug, Olaparib, to the Usual Chemotherapy (Temozolomide) for Advanced Neuroendocrine Cancer

    This phase II trial studies how well the addition of olaparib to the usual treatment, temozolomide, works in treating patients with neuroendocrine cancer (pheochromocytoma or paraganglioma) that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Drugs used in chemotherapy, such as temozolomide, 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. Giving olaparib with temozolomide may shrink or stabilize the cancer in patients with pheochromocytoma or paraganglioma better than temozolomide alone.
    Location: 116 locations

  • Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients with Newly Diagnosed Glioblastoma

    This randomized phase II trial studies how well dose-escalated photon intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as temozolomide, may make tumor cells more sensitive to radiation therapy. It is not yet known whether dose-escalated photon IMRT or proton beam radiation therapy is more effective than standard-dose radiation therapy with temozolomide in treating glioblastoma.
    Location: 150 locations

  • Treatment with Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination with Irinotecan and Temozolomide after Intensive Therapy for People with High-Risk Neuroblastoma (NBL)

    This phase II trial studies if dinutuximab, GM-CSF, isotretinoin in combination with irinotecan, and temozolomide (chemo-immunotherapy) can be given safely to patients with high-risk neuroblastoma after Consolidation therapy (which usually consists of two autologous stem cell transplants and radiation) who have not experienced worsening or recurrence of their disease. Dinutuximab represents a kind of cancer therapy called immunotherapy. Unlike chemotherapy and radiation, dinutuximab targets the cancer cells without destroying nearby healthy cells. Sargramostim helps the body produce normal infection-fighting white blood cells. Isotretinoin helps the neuroblastoma cells become more mature. These 3 drugs (standard immunotherapy) are already given to patients with high-risk neuroblastoma after Consolidation because they have been proven to be beneficial in this setting. Chemotherapy drugs, such as irinotecan and temozolomide, 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. They may also effect how well immunotherapy works on neuroblastoma cells. Giving chemo-immunotherapy after intensive therapy may work better in treating patients with high-risk neuroblastoma compared to standard immunotherapy.
    Location: 29 locations

  • CB-839 with Radiation Therapy and Temozolomide in Treating Patients with IDH-Mutated Diffuse Astrocytoma or Anaplastic Astrocytoma

    This phase 1b trial studies the side effects and best dose of glutaminase inhibitor CB-839 hydrochloride (CB-839) in combination with radiation therapy and temozolomide in treating patients with IDH-mutated diffuse or anaplastic astrocytoma. CB-839 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as temozolomide, 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. Giving CB-839 with radiation therapy and temozolomide may work better than surgery, radiation therapy, and temozolomide in treating patients with IDH-mutated diffuse astrocytoma or anaplastic astrocytoma.
    Location: 22 locations

  • A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma

    Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II / III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM.
    Location: 26 locations

  • Nanoparticle Albumin-Bound Rapamycin, Temozolomide, and Irinotecan Hydrochloride in Treating Pediatric Patients with Recurrent or Refractory Solid Tumors

    This phase I trial studies the side effects and best dose of nanoparticle albumin-bound rapamycin when given together with temozolomide and irinotecan hydrochloride in treating pediatric patients with solid tumors that have come back after a period of time during which the tumor could not be detected or has not responded to treatment. Nanoparticle albumin-bound rapamycin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as temozolomide and irinotecan 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. Giving nanoparticle albumin-bound rapamycin, temozolomide, and irinotecan hydrochloride may cause the cancer to stop growing or shrink for a period of time, and may lessen the symptoms that are caused by the cancer.
    Location: 21 locations

  • Pevonedistat, Irinotecan, and Temozolomide in Treating Patients with Recurrent or Refractory Solid Tumors or Lymphoma

    This phase I trial studies the side effects and best dose of pevonedistat when given together with irinotecan hydrochloride and temozolomide in treating patients with solid tumors, central nervous system (CNS) tumors, or lymphoma that have come back after a period of improvement (recurrent) or that do not respond to treatment (refractory). Pevonedistat and irinotecan may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, 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 pevonedistat, irinotecan hydrochloride, and temozolomide may work better in treating patients with solid tumors, central nervous system (CNS) tumors, or lymphoma compared to irinotecan and temozolomide alone.
    Location: 20 locations

  • Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent / Refractory Solid Tumors

    This study will evaluate palbociclib in combination with chemotherapy (temozolomide with irinotecan and topotecan with cyclophosphamide) in children, adolescents and young adults with recurrent or refractory solid tumors. The main purpose of this study is to evaluate the safety of palbociclib in combination with chemotherapy in order to estimate the maximum tolerated dose. Pharmacokinetics and efficacy of palbociclib in combination with chemotherapy will be evaluated.
    Location: 22 locations

  • Testing the Safety of the Study Drug Pamiparib (BGB-290) When Given with Different Doses of the Usual Chemotherapy (Temozolomide) for Patients with Recurrent Glioma Having the IDH1 / 2 Genetic Change

    This phase I / II trial studies the side effects and how well pamiparib and temozolomide work in treating patients with gliomas (brain tumors) with IDH1 / 2 mutations that have come back (recurrent). Pamiparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, 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. Giving pamiparib and temozolomide may work better in treating patients with recurrent gliomas compared to temozolomide alone.
    Location: 14 locations

  • Abemaciclib, DNA-PK / TOR Kinase Inhibitor CC-115, or Neratinib in Treating Patients with Brain Tumors after Biomarker Screening

    This randomized phase II trial studies how well abemaciclib, DNA-PK / TOR kinase inhibitor CC-115, or neratinib works in treating patients with brain tumors after biomarker screening. Drugs such as abemaciclib, DNA-PK / TOR kinase inhibitor CC-115, or neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Screening tumor samples for biomarkers may help doctors to determine if certain treatments work better on patients with certain biomarkers. Giving abemaciclib, DNA-PK / TOR kinase inhibitor CC-115, or neratinib may work better in treating patients with brain tumors.
    Location: 13 locations

  • Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001

    This is a Phase 2 study of newly diagnosed patients with high grade glioma (HGG) undergoing standard radiation therapy and temozolomide treatment. BMX-001 added to radiation therapy and temozolomide has the potential not only to benefit the survival of high grade glioma patients but also to protect against deterioration of cognition and impairment of quality of life. BMX-001 will be given subcutaneously first with a loading dose zero to four days prior to the start of chemoradiation and followed by twice a week doses at one-half of the loading dose for the duration of radiation therapy plus two weeks. Both safety and efficacy of BMX-001 will be evaluated. Impact on cognition will also be assessed. Eighty patients will be randomized to the treatment arm that will receive BMX-001 while undergoing chemoradiation and 80 patients randomized to receive chemoradiation alone. The sponsor hypothesizes that BMX-001 when added to standard radiation therapy and temozolomide will be safe at pharmacologically relevant doses in patients with newly diagnosed high grade glioma. The sponsor also hypothesizes that the addition of BMX-001 will positively impact the overall survival and improve objective measures of cognition in newly diagnosed high grade glioma patients.
    Location: 9 locations

  • A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma

    This is a global, Phase 1 / 2, multicenter, open-label study. The clinical study will include of Phase 1: Dose Escalation (non-randomized, dose finding study) and Phase 2: Dose Expansion (randomized efficacy exploration). For Phase 1, the purpose of this study is to assess the maximum tolerated dose (MTD), recommend phase 2 dose (RP2D), preliminary efficacy, and safety of selinexor in combination with SoC therapy for newly diagnosed glioblastoma multiforme (GBM) (nGBM) or recurrent GBM (rGBM). The study will independently evaluate 3 different combination regimens in 3 treatment arms in participants with nGBM O6-methylguanine-DNA-methyltransferase [MGMT] promotor unmethylated [uMGMT] disease in Arm A, MGMT methylated [mMGMT]) in Arm B, and participants with rGBM regardless of MGMT status in Arm C. The second phase of the study will compare selinexor+SoC treatments versus SoC treatment alone in the three treatment Arms.
    Location: 10 locations

  • Temozolomide, Cisplatin, and Nivolumab for the Treatment of Patients with MMR-Proficient Locally Advanced, Unresectable or Metastatic Colorectal Cancer

    This phase II trial studies how well the combination of cisplatin, nivolumab, and temozolomide works in treating patients with colorectal cancer that has spread to nearby tissues or lymph nodes and cannot be removed by surgery (locally advanced, unresectable) or has spread to other places in the body (metastatic) that is mismatch repair (MMR)-proficient. Cisplatin and temozolomide are both cytotoxic chemotherapies that work mostly by causing damage to the DNA in tumor cells, which can cause those cells to stop growing and die. Combining the two chemotherapy drugs may also cause changes (mutations) in the tumor's DNA, which triggers an immune response against the cancer and the new mutations caused by the drugs. Nivolumab is an antibody, like the proteins made by the immune system to protect the body from harm. Nivolumab blocks the protein PD-1 (programmed cell death receptor-1) that usually acts as a “brake” on the immune system. Blocking this protein is like releasing the brakes, so that the immune system can target tumor cells and destroy them. Giving cisplatin, nivolumab, and temozolomide together may work better to shrink or stabilize the cancer better than each drug alone in patients with colorectal cancer.
    Location: 7 locations

  • Irinotecan Hydrochloride, Temozolomide, and Combination Chemotherapy in Treating Patients with Newly Diagnosed Ewing Sarcoma

    This phase II trial studies how well irinotecan hydrochloride, temozolomide, and combination chemotherapy work in treating patients with newly diagnosed Ewing sarcoma. Drugs used in chemotherapy, such as irinotecan hydrochloride, temozolomide, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells, or by stopping them from dividing.
    Location: 7 locations

  • BGB-290 and Temozolomide in Treating Adolescents and Young Adults with IDH1 / 2-Mutant Newly Diagnosed or Recurrent Grade I-IV Gliomas

    This phase I trial studies the side effects and best dose of BGB-290 and temozolomide in treating adolescents and young adults with IDH1 / 2-mutant grade I-IV glioma that is newly diagnosed or has come back (recurrent). PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as BGB-290, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Drugs used in chemotherapy, such as temozolomide 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. Giving BGB-290 and temozolomide may work better in treating adolescents and young adults with IDH1 / 2-mutant grade I-IV glioma.
    Location: 22 locations

  • GMCI, Nivolumab, Radiation Therapy, and Temozolomide in Treating Patients with Newly Diagnosed High-Grade Gliomas

    This phase I trial studies the side effects and best dose of aglatimagene besadenovec and valacyclovir (gene mediated cytotoxic immunotherapy [GMCI]), nivolumab, radiation therapy, and temozolomide in treating patients with newly diagnosed high-grade gliomas. Aglatimagene besadenovec and valacyclovir may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, 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. Giving GMCI, nivolumab, radiation therapy, and temozolomide may work better in treating patients with high-grade gliomas.
    Location: 7 locations

  • Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM)

    Background: GBM refers to a specific kind of brain cancer called glioblastoma. The standard treatment for GBM is radiation plus temozolomide, an oral chemotherapy drug. Pembrolizumab is an immune therapy that is now used to treat other cancers. The addition of pembrolizumab to the standard treatment of radiation and temozolomide has been shown to be well tolerated. Researchers want to see if adding a vaccine made from the person s own tumor will improve the effect of the pembrolizumab. The vaccine which is developed from fresh tumor taken at the time of surgery is called HSPPC-96. Objectives: To see if the adding pembrolizumab and HSPPC-96 improves the standard treatment for glioblastoma multiforme. Eligibility: Adults at least 18 years old with glioblastoma. Design: Participants will be screened with typical cancer tests: Brain scan Medical history Blood and urine tests Questions about quality of life and symptoms These tests will be repeated throughout the study. Participants will have surgery to remove their tumor. A tissue sample from the tumor will be sent to a lab. A vaccine will be made from it. Some participants will get pembrolizumab and vaccine. Some will get pembrolizumab and placebo. Participants will not know which they get. Participants will get radiation for 6 weeks. Participants will take temozolomide by mouth before each treatment. Participants will get pembrolizumab by IV for 30 minutes 3 times over the radiation cycle. Participants will keep taking the 2 drugs every few weeks for about a year. Some may take pembrolizumab for an additional year. Most participants will get the vaccine or placebo after radiation. They will get it 5 times over 6 weeks. Some participants will continue to get the vaccine every few weeks for 1 or 2 years. Participants will repeat the screening tests when they stop study treatment. They will also have follow-up phone calls.
    Location: 6 locations

  • Olaparib and Temozolomide with or without Irinotecan Hydrochloride in Treating Patients with Recurrent or Metastatic Ewing Sarcoma or Rhabdomyosarcoma Previously Treated with Chemotherapy

    This phase I trial studies the side effects and best dose of olaparib and temozolomide in treating patients with Ewing sarcoma or rhabdomyosarcoma that has returned (recurrent) or spread to other places in the body (metastatic) or after previous treatment with chemotherapy. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, 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. Irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving olaparib and temozolomide with irinotecan may be a better treatment for Ewing sarcoma or rhabdomyosarcoma.
    Location: 4 locations

  • Study to Assess Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Participants With Locally Advanced or Metastatic Solid Tumors

    The primary objective of this study is to determine the safety and tolerability of pamiparib, the maximum tolerated dose (MTD) or maximum administered dose (MAD) for pamiparib combined with TMZ, to select the recommended Phase 2 dose (RP2D) and schedule of pamiparib in combination with TMZ, and to determine the antitumor activity of pamiparib in combination with TMZ.
    Location: 3 locations

  • Ibrutinib, Temozolomide, Etoposide, Pegylated Liposomal Doxorubicin Hydrochloride, Dexamethasone, and Rituximab in Treating Patients with Primary Central Nervous System Lymphoma

    This phase I trial studies the side effects and best dose of ibrutinib when given together with temozolomide, etoposide, pegylated liposomal doxorubicin hydrochloride, dexamethasone, and rituximab in treating patients with central nervous system lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as temozolomide, etoposide, and pegylated liposomal doxorubicin hydrochloride, 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. Anti-inflammatory drugs, such as dexamethasone, lower the body’s immune response and are used with other drugs in the treatment of some types of cancer. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving ibrutinib with rituximab and combination chemotherapy may kill more cancer cells.
    Location: 3 locations


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