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 76
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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: 129 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: 205 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: 152 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. Drugs used in chemotherapy, 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 work better in treating pediatric patients with solid tumors.
    Location: 21 locations

  • Pevonedistat, Irinotecan Hydrochloride, 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 hydrochloride 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 hydrochloride and temozolomide alone.
    Location: 20 locations

  • CB-839 with Radiation Therapy and Temozolomide in Treating Participants 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 participants 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. 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 stopping them from spreading. Giving CB-839 with radiation therapy and temozolomide may work better in treating participants with IDH-mutated diffuse astrocytoma or anaplastic astrocytoma.
    Location: 16 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

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

    This study will evaluate palbociclib in combination with chemotherapy (temozolomide and irinotecan) 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: 18 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: 16 locations

  • Acetazolamide Sodium and Temozolomide in Treating Adult Patients with Newly Diagnosed MGMT Promoter-Methylated Malignant Glioma

    This phase I trial studies the side effects and best dose of acetazolamide sodium when given together with temozolomide in treating adult patients with newly diagnosed MGMT promoter-methylated malignant glioma. Acetazolamide sodium 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 acetazolamide sodium and temozolomide may work better in treating adult patients with newly diagnosed malignant glioma.
    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

  • 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: 7 locations

  • MPACT Study to Compare Effects of Targeted Drugs on Tumor Gene Variations

    This phase II trial studies molecular profiling-based assignment of cancer therapy (MPACT) in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Adavosertib, everolimus, and trametinib are drugs that each target a specific variation in tumors by blocking different proteins needed for cell growth. Veliparib blocks an enzyme that helps repair deoxyribonucleic acid (DNA) damaged by chemotherapy, which may help chemotherapy drugs work better. It is not yet known whether testing patients for variations in their tumor and assigning treatment targeting the variation is more effective than standard non-targeted therapy in treating advanced solid tumors.
    Location: 6 locations

  • Testing the Safety of the Study Drug Pamiparib 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: 5 locations

  • ESP1 / SARC025 Global Collaboration: A Phase I Study of a Combination of the PARP Inhibitor, Niraparib and Temozolomide and / or Irinotecan Patients With Previously Treated, Incurable Ewing Sarcoma

    The purpose of this study is to define the dose-limiting toxicities and maximum tolerated dose of the poly ADP-ribose polymerase inhibitor niraparib and escalating doses of temozolomide and / or irinotecan in patients with pre-treated incurable Ewing sarcoma.
    Location: 5 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

    This study is to evaluate the safety, efficacy and clinical activity of BGB-290 and temozolomide (TMZ) in participants with locally advanced or metastatic solid tumors.
    Location: 5 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

  • 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. BGB-290 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 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

  • A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma

    The standard of care for newly diagnosed glioblastoma includes surgery, involved-field radiotherapy, and concomitant and six cycles of maintenance temozolomide chemotherapy, however the prognosis remains dismal. Marizomib has been tested in patients with newly diagnosed and recurrent glioblastoma in phase I and phase II studies. In patients with recurrent glioblastoma, marizomib was administered as a single agent or in combination with bevacizumab (NCT02330562). Based on encouraging observations, a phase I / II trial of marizomib in combination with TMZ / RT -->TMZ in newly diagnosed glioblastoma has been launched (NCT02903069) which explores safety and tolerability of this triple combination and which shall help to determine the dose for further clinical trials in glioblastoma. In this context, given that marizomib has been established as a safe addition to the standard TMZ / RT -->TMZ, a phase III study is considered essential to establishing its impact on overall survival.
    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. Drugs used in chemotherapy, such as temozolomide, etoposide, pegylated liposomal doxorubicin hydrochloride, 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. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and 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

  • Temozolomide and Targeted or Standard Brain Radiation Therapy in Treating Patients with Newly Diagnosed Glioblastoma Multiforme

    This randomized phase II trial studies how well an increased dose of radiation therapy applied to a specific part of the brain works compared to standard radiation therapy when given with temozolomide in treating patients with a newly diagnosed brain tumor, such as glioblastoma multiforme. The brain contains cells called neural progenitor cells (NPC) that may be important in the brain’s response to injury but may also contribute to tumor recurrence. Subventricular zone radiation therapy targeting these cells may improve the local control and delay the brain tumor from coming back. 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 subventricular zone radiation therapy and temozolomide are more effective than standard radiation therapy and temozolomide in treating patients with glioblastoma multiforme.
    Location: 4 locations

  • Low-Dose Fractionated Radiation Therapy and Temozolomide in Treating Patients with Recurrent Anaplastic Astrocytoma or Glioblastoma Multiforme

    This phase II trial studies the side effects and how well giving low-dose fractionated radiation therapy and temozolomide works in treating patients with anaplastic astrocytoma or glioblastoma multiforme that has returned after a period of improvement. 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. Radiation therapy may make it easier for chemotherapy drugs to enter tumor cells and may work better when given with temozolomide in treating patients with recurrent anaplastic astrocytoma or glioblastoma multiforme.
    Location: 3 locations

  • Talazoparib and Low-Dose Temozolomide in Treating Participants with Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer

    This phase II trial studies how effective talazoparib and temozolomide are for treating participants with extensive-stage small cell lung cancer that has come back after an initial chemotherapy treatment. Talazoparib, a PARP inhibitor, may stop the growth of tumor cells by preventing them from repairing their DNA. 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 talazoparib and temozolomide may work better in treating participants with extensive-stage small cell lung cancer than either one alone.
    Location: 2 locations


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