Clinical Trials Using Temozolomide

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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 74
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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 randomized 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. 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: 506 locations

  • Temozolomide with or without Veliparib in Treating Patients with Newly Diagnosed Glioblastoma Multiforme

    This randomized phase II / III trial studies how well temozolomide and veliparib work compared to temozolomide alone in treating patients with newly diagnosed glioblastoma multiforme. 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. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether temozolomide is more effective with or without veliparib in treating glioblastoma multiforme.
    Location: 384 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: 194 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: 169 locations

  • The Toca 5 Trial: Toca 511 & Toca FC Versus Standard of Care in Patients With Recurrent High Grade Glioma

    This is a multicenter, randomized, open-label phase 2 / 3 study of Toca 511 and Toca FC versus standard of care that comprises Investigator's choice of single agent chemotherapy (lomustine or temozolomide) or bevacizumab administered to subjects undergoing resection for first or second recurrence (including this recurrence) of GBM or AA. Subjects meeting all of the inclusion and none of the exclusion criteria will be randomized prior to surgery in a 1:1 ratio to receive either Toca 511 and Toca FC (Experimental arm, Arm T) or control treatment with one option of standard of care (Arm SOC). Stratification will be done by IDH1 mutation status. A second stratification factor is based on the patient's Karnofsky Performance Score (KPS) (70-80 vs 90-100). Further, to account for potential differences in treatment choices for the control arm in regions, the trial will be stratified by geographical region during the randomization process. Funding Source - FDA OOPD
    Location: 22 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

  • An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)

    The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving Nivolumab in addition to temozolomide plus radiation therapy.
    Location: 22 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 giving together with irinotecan hydrochloride and temozolomide in treating patients with solid tumors or lymphoma that have come back after a period of improvement or that do not respond to treatment. 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 or lymphoma.
    Location: 16 locations

  • An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)

    The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.
    Location: 18 locations

  • A Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification

    This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification. In addition, there is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in participants with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.
    Location: 14 locations

  • Metformin Hydrochloride, Vincristine Sulfate, Irinotecan Hydrochloride, and Temozolomide in Treating Younger Patients with Relapsed or Refractory Solid Tumors

    This phase I trial studies the side effects and best dose of metformin hydrochloride when given together with vincristine sulfate, irinotecan hydrochloride, and temozolomide in treating younger patients with solid tumors that have returned after a period of improvement (relapsed) or have not responded to previous treatment (refractory). Metformin hydrochloride may slow the growth of tumor cells and may be an effective treatment for solid tumors. Drugs used in chemotherapy, such as vincristine sulfate, 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. Giving metformin hydrochloride together with vincristine sulfate, irinotecan hydrochloride, and temozolomide may kill more tumor cells.
    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: 9 locations

  • A Study Assessing BGB-290 With Radiation and / or Temozolomide (TMZ) in Subjects With Newly Diagnosed or Recurrent Glioblastoma

    This study is to evaluate the safety, efficacy and clinical activity of BGB-290 in combination with radiation therapy (RT) and / or temozolomide (TMZ) in subjects with newly diagnosed or recurrent / refractory glioblastoma.
    Location: 11 locations

  • Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors

    In this study, investigators will conduct a phase I / II trial in recurrent (temozolomide resistant) glioma patients. The overall goal of this study is to provide a foundation for future studies with indoximod tested in newly diagnosed glioblastoma patients with radiation and temozolomide, or in combination with vaccine therapies.
    Location: 7 locations

  • PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma

    This is an international multicenter, open-label, randomized controlled trial (RCT) of single-agent intralesional PV-10 versus systemic chemotherapy or intralesional oncolytic viral therapy to assess treatment of locally advanced cutaneous melanoma in patients who (1) are not candidates for targeted therapy and (2) are not candidates for an immune checkpoint inhibitor. Subjects in the comparator arm will receive the Investigator's choice of dacarbazine (DTIC), temozolomide (TMZ) or intralesional talimogene laherparepvec as determined by Investigator preference and standard of care in the Investigator's country or region. Effectiveness will be assessed by comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms.
    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: 6 locations

  • Adavosertib, Radiation Therapy, and Temozolomide in Treating Patients with Newly Diagnosed or Recurrent Glioblastoma

    This phase I trial studies the side effects and best dose of adavosertib when given together with radiation therapy and temozolomide in treating patients with newly diagnosed or glioblastoma that has come back. Adavosertib 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 adavosertib, radiation therapy, and temozolomide may work better in treating patients with newly diagnosed or recurrent glioblastoma.
    Location: 12 locations

  • Temozolomide and Lapatinib Ditosylate in Treating Patients with Recurrent Low-Grade Ependymoma

    This phase II trial studies how well temozolomide and lapatinib ditosylate work in treating patients with low-grade ependymoma that has come back (recurrent). 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. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Giving temozolomide and lapatinib ditosylate together may kill more tumor cells.
    Location: 6 locations

  • ESP1 / SARC025 Global Collaboration: A Phase I Study of a Combination of the PARP Inhibitor, Niraparib and Temozolomide or Irinotecan in 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 in patients with pre-treated incurable Ewing sarcoma.
    Location: 5 locations

  • Olaparib and Temozolomide with or without Irinotecan Hydrochloride in Treating Patients with Recurrent or Metastatic Ewing Sarcoma 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 that has returned or spread to other places in the body 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.
    Location: 5 locations

  • Study of Marizomib With Temozolomide and Radiotherapy in Patients With Newly Diagnosed Brain Cancer

    This study is for newly diagnosed WHO Grade IV malignant glioma patients to determine whether an investigational drug known as marizomib (MRZ) will improve the treatment of newly diagnosed glioblastoma patients by delaying the growth of the cancer, reducing the size of the tumor, and / or improving survival. Marizomib (MRZ) is being added to standard-of-care treatments of radiotherapy (RT), temozolomide (TMZ), and Optune.
    Location: 4 locations

  • Olaparib and Temozolomide in Treating Patients with Recurrent Small Cell Lung Cancer

    This phase I / II trial studies the side effects and best dose of olaparib and temozolomide and to see how well they work in treating patients with small cell lung cancer that has come back (recurrent). 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. Giving olaparib and temozolomide may be a better treatment for recurrent small cell lung cancer.
    Location: 4 locations

  • Temozolomide and Pazopanib Hydrochloride in Treating Patients with Advanced Pancreatic Neuroendocrine Tumors That Cannot Be Removed by Surgery

    This phase I / II trial studies the side effects and best dose of temozolomide and pazopanib hydrochloride when given together and to see how well they work in treating patients with pancreatic neuroendocrine tumors (PNET) that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) and cannot be removed by surgery. 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. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for tumor growth. Giving temozolomide together with pazopanib hydrochloride may be a better treatment for patients with PNET.
    Location: 4 locations

  • Bavituximab, Radiation Therapy, and Temozolomide in Treating Patients with Glioblastoma

    This phase II trial studies how well bavituximab with radiation therapy and temozolomide work in treating patients with glioblastoma. Monoclonal antibodies, such as bavituximab, may interfere with the ability of tumor cells to grow and spread. 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 bavituximab, temozolomide with radiation therapy may kill more tumor cells and work better in treating glioblastoma.
    Location: 3 locations

  • Pazopanib Hydrochloride, Irinotecan, and Temozolomide in Treating Children and Young Adults with Relapsed or Refractory Sarcoma

    This phase I clinical trial studies the side effects and best dose of pazopanib hydrochloride when given together with irinotecan and temozolomide in treating children and young adults with sarcoma that has come back or does not respond to treatment. Pazopanib hydrochloride, irinotecan, and temozolomide may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 3 locations


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