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 26-50 of 84

  • Study to Evaluate Ibudilast and TMZ Combo Treatment in Newly Diagnosed and Recurrent Glioblastoma

    Part 1 is an open-label, single-arm, dose escalation study of MN-166 (ibudilast) and temozolomide (TMZ) combination treatment. Evaluate safety and tolerability of ibudilast (MN-166) and TMZ combination treatment for 1 cycle (28 days); determine dosage in dose-finding study. Part 2 will evaluate efficacy of fixed-dose MN-166 (ibudilast) and TMZ combination treatment for 6 cycles (~6 months) until disease progression, unacceptable tolerability and / or toxicity or loss of life.
    Location: 2 locations

  • 18F-DOPA-PET / MRI Scan in Imaging Elderly Patients with Newly Diagnosed Grade IV Malignant Glioma or Glioblastoma during Planning for a Short Course of Proton Beam Radiation Therapy

    This phase II trial studies how well fluorodopa F 18-positron emission tomography / magnetic resonance imaging scan (18F-DOPA-PET / MRI) works in imaging elderly patients with newly diagnosed grade IV malignant glioma or glioblastoma during planning for a short course of proton beam radiation therapy. 18F-DOPA is a chemical tracer that highlights certain cells during imaging. PET scan, is a metabolic imaging technique which takes advantage of how tumor cells take up nutrients differently than normal tissue. MRI scans are used to guide radiation therapy for most brain tumors. Hypofractionated proton beam therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Using 18FDOPA-PET scans along with MRI scans may be able to provide the radiation doctor with information on tumor tissue versus normal, healthy tissue and may help the doctor more accurately plan the radiation treatment.
    Location: 2 locations

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

    This phase II trial studies how effective talazoparib and temozolomide are for treating patients with extensive-stage small cell lung cancer that has come back (relapsed) 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 patients with extensive-stage small cell lung cancer than either one alone.
    Location: 2 locations

  • Temozolomide in Treating Patients with Advanced SDH-Mutant Gastrointestinal Stromal Tumor

    This phase II trial studies how well temozolomide work in treating patients with succinate dehydrogenase (SDH)-mutant gastrointestinal stromal tumor. 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.
    Location: 2 locations

  • Vaccine Therapy, Radiation Therapy, Pembrolizumab, and Temozolomide in Treating Patients with Newly Diagnosed Glioblastoma

    This phase I trial studies the side effects and best dose of neoantigen-based melanoma-poly-L-lysine carboxymethylcellulose (ICLC) vaccine and how well it works when given together with radiation therapy, pembrolizumab, and temozolomide in treating patients with newly diagnosed glioblastoma. Glioblastomas have mutations (changes in genetic material) that are specific to an individual patient’s tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body’s own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the body fight any tumor cells that could cause the glioblastoma to come back in the future. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. 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 personalized vaccine together with radiation therapy, pembrolizumab, and temozolomide may kill more tumor cells.
    Location: 2 locations

  • TRC102 and Temozolomide in Treating Patients with Relapsed Solid Tumors or Lymphomas

    This phase I / II trial studies the side effects and best dose of TRC102 and temozolomide in treating patients with solid tumors or lymphomas that have come back after a period of improvement (relapsed). Chemotherapy drugs, such as TRC102 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. TRC102 may also increase the effectiveness of temozolomide against tumor cells. Giving TRC102 and temozolomide together may kill more tumor cells compared to temozolomide alone.
    Location: 2 locations

  • Chemotherapy and Radiation Therapy for the Treatment of IDH Wildtype Gliomas or Non-histological (Molecular) Glioblastomas

    This phase II trial studies how well temozolomide and radiation therapy work in treating patients with IDH wildtype historically lower grade gliomas or non-histological molecular glioblastomas. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more 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. The goal of this clinical research study is to compare receiving new radiation therapy doses and volumes to the prior standard treatment for patients with historically grade II or grade III IDH wild-type gliomas, which may now be referred to as IDH wildtype molecular glioblastomas at some institutions. Receiving temozolomide in combination with radiation therapy may also help to control the disease.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Multiparametric MR-Guided High Dose Adaptive Radiotherapy and Temozolomide for the Treatment of Newly Diagnosed Grade IV Gliomas

    This phase II trial studies the effect of adaptive, high dose radiotherapy guided by advanced magnetic resonance imaging (MRI) techniques and temozolomide in treating patients with newly diagnosed grade IV glioma. Adaptive, dose-intensified radiation therapy delivers radiation to certain regions of the tumor that have greater activity, as identified by advanced MRI imaging. The advanced imaging used for the radiation boost is a type of MRI called diffusion weighted MRI (or “DW-MRI”) and perfusion MRI. “Dose-intensified” means that these regions of the tumor receives a higher dose of radiation, in addition to regular regions of the tumor receiving standard doses of radiation. “Adaptive” means that the treatment plan is re-evaluated and adjusted midway through the radiation schedule to ensure the radiation remains focused on the areas that continue to have greater tumor activity. 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 adaptive, high dose chemoradiation guided by advanced MRI may work better in treating patients with glioma compared to standard chemoradiation.
    Location: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan

  • Nedisertib and Radiation Therapy, Followed by Temozolomide for the Treatment of Patients with Newly Diagnosed MGMT Unmethylated Glioblastoma or Gliosarcoma

    This phase I trial investigates the side effects and best dose of nedisertib, and to see how well it works in combination with radiation therapy in treating patients with newly diagnosed MGMT unmethylated glioblastoma or gliosarcoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Nedisertib may further stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 nedisertib with radiation therapy may work better than radiation therapy alone in treating patients with glioblastoma or gliosarcoma.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Temozolomide with Osimertinib or Lorlatinib for the Treatment of Stage IV Non-small Cell Lung Cancer in Patients with CNS Progression on Either Osimertinib or Lorlatinib

    This phase I trial is to find out the best dose of temozolomide when given together with osimertinib or lorlatinib in treating patients with stage IV non-small cell lung cancer that becomes worse or spreads to the central nervous system (CNS) under the treatment of osimertinib or lorlatinib. Temozolomide may help block the formation of growths that may become cancer. Osimertinib may bind to and inhibit the activity of mutant forms of EGFR. Lorlatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Adding temozolomide to osimetinib or lorlatinib may kill more tumor cells.
    Location: University of Colorado Hospital, Aurora, Colorado

  • Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM

    To test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy.
    Location: 6 locations

  • Selinexor (KPT-330) in Combination With Temozolomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma

    Background: Glioblastoma is a type of brain cancer. Treatments include radiation, chemotherapy, and surgery. But survival rates are poor. Researchers think that the drug selinexor, when combined with chemotherapy and radiation, might help. Objective: To learn the highest dose of selinexor that people with brain cancer can tolerate when given with temozolomide and radiation therapy. Eligibility: People ages 18 and older with brain cancer that has not been treated with chemotherapy or radiation Design: Participants will be screened under another protocol. Before participants start treatment, they will have tests: Neurological and physical evaluations Blood and urine tests Possible CT scan or MRI of the brain if they have not had one in 3 weeks. Participants will lie in a machine that takes pictures of the body. They may have a dye injected into a vein. Surveys about their well-being Participants will have radiation to the brain for up to 6 weeks. This will usually be given once a day, Monday through Friday. Starting the second day of radiation, participants will take selinexor by mouth once a week. They will take it in weeks 1, 2, 4, and 5. The timing may be changed. Starting the first day of radiation, participants will take temozolomide by mouth once a day until they complete radiation. Participants will have blood tests once per week during treatment. Participants will have a follow-up visit 1 month after they complete treatment. Then they will have visits at least every 2 months for the first 2 years, then at least every 3 months for another year. Visits will include MRIs and blood tests. ...
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM

    This study aims to investigate effect of Nivolumab and Temozolomide vs Temozolomide alone on overall survival in newly diagnosed elderly patients with glioblastoma. Who is it for? You may be eligible to join this study if you are aged 65 years or above, with newly diagnosed histologically confirmed GBM (WHO grade IV glioma including gliosarcoma) following surgery. The study aims to evaluate whether the combination of adjuvant nivolumab with temozolomide improves overall survival outcomes for this patient population. The outcome of the study will help determine the most effective treatment for patients with glioblastoma in the future.
    Location: Duke University Medical Center, Durham, North Carolina

  • Temozolomide and Olaparib for the Treatment of MGMT Promoter Hypermethylated Relapsed or Refractory Colorectal Cancer

    This phase II trial studies how well temozolomide and olaparib work for the treatment of MGMT promoter hypermethylated colorectal cancer that has come back (relapsed) or does not response to treatment (refractory). 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. Olaparib inhibits the ability for tumors to repair DNA and is most effective in tumors that already have impaired DNA repair. Temozolomide and olaparib may work better than either one alone in treating patients with colorectal cancer.
    Location: Yale University, New Haven, Connecticut

  • Drug Resistant Immunotherapy for the Treatment of Newly Diagnosed Glioblastoma in Patients Receiving Maintenance Temozolomide

    This phase I trial studies the possible benefits and / or side effects of drug resistant immunotherapy in treating patients with a newly diagnosed brain tumor, called glioblastoma and who are receiving maintenance temozolomide. Drug resistant immunotherapy (DRI gamma / delta T cells) consist of immune cells known as gamma / delta T cells that are known to attack brain cancer. Gamma / delta T cells, which normally are killed by chemotherapy, are modified to be resistant to the effects of chemotherapy by inserting a gene known as methylguanine methyltransferase (MGMT) into the cell using a lentivector, which is a virus designed especially for this purpose.
    Location: University of Alabama at Birmingham Cancer Center, Birmingham, Alabama

  • Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG

    Indoximod was developed to inhibit the IDO (indoleamine 2,3-dioxygenase) enzymatic pathway, which is important in the natural regulation of immune responses. This potent immune suppressive mechanism has been implicated in regulating immune responses in settings as diverse as infection, tissue / organ transplant, autoimmunity, and cancer. By inhibiting the IDO pathway, we hypothesize that indoximod will improve antitumor immune responses and thereby slow the growth of tumors. The central clinical hypothesis for the GCC1949 study is that inhibiting the pivotal IDO pathway by adding indoximod immunotherapy during chemotherapy and / or radiation is a potent approach for breaking immune tolerance to pediatric tumors that will improve outcomes, relative to standard therapy alone. This is an NCI-funded (R01 CA229646, MPI: Johnson and Munn) open-label phase 2 trial using indoximod-based combination chemo-radio-immunotherapy for treatment of patients age 3 to 21 years who have progressive brain cancer (glioblastoma, medulloblastoma, or ependymoma), or newly-diagnosed diffuse intrinsic pontine glioma (DIPG). Statistical analysis will stratify patients based on whether their treatment plan includes up-front radiation (or proton) therapy in combination with indoximod. Central review of tissue diagnosis from prior surgery is required, except non-biopsied DIPG. This study will use the "immune-adapted Response Assessment for Neuro-Oncology" (iRANO) criteria for measurement of outcomes. Planned enrollment is up to 140 patients.
    Location: 2 locations

  • Nivolumab, BMS-986205, and Radiation Therapy with or without Temozolomide in Treating Patients with Newly Diagnosed Glioblastoma

    This phase I trial studies the side effects of nivolumab, BMS-986205, and standard radiation therapy with or without temozolomide in treating patients with new diagnosed glioblastoma. Immunotherapy with nivolumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. BMS-986205 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 nivolumab and BMS-986205 may work better compared to radiation therapy and temozolomide alone in treating patients with newly diagnosed glioblastoma.
    Location: Northwestern University, Chicago, Illinois

  • Talazoparib and Temozolomide in Treating Patients with Metastatic Castration Resistant Prostate Cancer with No Mutations in DNA Damage Repair

    This phase Ib / II trial studies the side effects and best dose of talazoparib and temozolomide and how well they work in treating patients with castration resistant prostate cancer that has spread to other places in the body (metastatic) and that does not have mutations in DNA damage repair. DNA damage repair (DDR) is a complex series of processes by which a cell identifies and fixes damage to its DNA, and DDR mutations are common in some types of cancer cells. Talazoparib is a type of medication called a PARP inhibitor. This kind of medication works by stopping cancer cells from repairing damage to themselves and their DNA, which can lead to the death of the cancer cells. Temozolomide is a chemotherapy drug that works by damaging the genetic “instructions” (DNA) in tumor cells that tell the cells to stop reproducing, which can cause them to die. Giving talazoparib and temozolomide may work better in treating patients with castration resistant prostate cancer compared to standard care.
    Location: Memorial Sloan Kettering Cancer Center, New York, New York

  • Short Course Chemo-Radiation Therapy for the Treatment of Newly Diagnosed Glioblastoma

    This phase I / II trial compares the side effects of two different treatment schedules of chemo-radiation therapy (chemotherapy plus radiation therapy) and to see how well they work in treating patients with newly diagnosed glioblastoma. Standard of care treatment after surgery consists of chemotherapy and radiation therapy to treat any remaining suspicious tumor seen on a scan. 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. Radiation therapy uses high energy x-rays used to kill tumor cells and shrink tumors. This trial compares a newer 1-week and 3-week radiation treatment schedules with temozolomide chemotherapy given at the same time for both schedules. The two treatments may provide similar tumor control but might differ slightly in the amount of side effects including a difference in the effects on lymphocyte (white blood cell involved in immune responses to fight tumors) counts.
    Location: UPMC-Shadyside Hospital, Pittsburgh, Pennsylvania

  • Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, and Rituximab (TEDDI-R) in Aggressive B-cell Lymphomas With Secondary Involvement of the Central Nervous System (CNS)

    Background: Secondary central nervous system lymphoma (sCNSL) is cancer that has spread to the central nervous system. Most drugs used to treat it do not cross the blood-brain barrier. This makes it hard to treat. Researchers hope that a new combination of drugs may be able to help. Objective: To find a better way to treat sCNSL. Eligibility: People ages 18 and older with sCNSL Design: Participants will be screened with: - Medical history - Physical exam - Blood, urine, and heart tests - Eye exam - Tissue or tumor biopsy - Collection of cerebrospinal fluid - CT, PET, and MRI scans: Participants will like in a machine that takes pictures of the body. - Bone marrow aspirations or biopsies: A needle will be inserted into the participant s hipbone. The needle will remove a small amount of marrow. Participants will take the study drugs in 21-day cycles. They will take some drugs by mouth. They will take others through a catheter: A small tube will be inserted into a vein in the arm, neck, or chest. They may have drugs given through a catheter placed through the brain or injected into the spinal canal. Participants will have regular visits during the study. These will include repeats of the screening test. They may also provide a saliva sample or have a cheek swab. Participants will have up to 4 treatment cycles. Participants will have a follow-up visit 30 days after their last treatment dose. Then they will have visits every 3-6 months for 3 years and then yearly....
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • A Vaccine (pp65 Loaded DC Vaccine) for the Treatment of Newly-Diagnosed Grade IV Unmethylated Glioma, I-ATTAC Study

    This phase II trial studies how well a vaccine (pp65 loaded DC vaccination) works for the treatment of newly-diagnosed grade IV unmethylated glioma. CMV pp65 DC vaccine may help to activate the immune system and help the body fight off the tumor cells in the brain.
    Location: Duke University Medical Center, Durham, North Carolina

  • Niraparib, Temozolomide and Atezolizumab in Treating Patients with Advanced Solid Tumors and Extensive-Stage Small Cell Lung Cancer with a Complete or Partial Response to Platinum-Based First-Line Chemotherapy

    This phase Ib / II trial studies the best dose of temozolomide and how well it works with niraparib and atezolizumab in treating patients with solid tumors that have spread to other places in the body (advanced) and extensive-stage small cell lung cancer with a complete or partial response to platinum-based first-line chemotherapy. 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. Niraparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving temozolomide, niraparib and atezolizumab may work better in treating patients with advanced solid tumors and extensive-stage small cell lung cancer.
    Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California

  • Nivolumab and Temozolomide in Treating Patients with Recurrent or Refractory Small-Cell Lung Cancer or Advanced Neuroendocrine Cancer

    This phase II trial studies how well nivolumab and temozolomide work in treating patients with small-cell lung cancer that has come back or does not respond to treatment, or neuroendocrine cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. 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 nivolumab and temozolomide may work better in treating patients with small-cell lung cancer and neuroendocrine cancer.
    Location: Ohio State University Comprehensive Cancer Center, Columbus, Ohio

  • Tumor Treating Fields With Chemoradiation in Newly Diagnosed GBM

    The study is an open-label pilot study in newly diagnosed glioblastoma patients following surgery. Eligible patients will receive treatment with tumor treating fields therapy using the Optune device starting less than 2 weeks prior to start of chemoradiation. Patients will receive radiation and temozolomide at a routine treatment dose and schedule.
    Location: UCSF Medical Center-Mount Zion, San Francisco, California

  • A Vaccine (pp65 Loaded DC Vaccine) with or without Varlilumab in Treating Patients with Glioblastoma

    This phase II trial studies how well a vaccine (pp65 loaded DC vaccine) with or without varlilumab works in treating patients with glioblastoma. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Pre-conditioning the vaccination site with varlilumab may help the pp65 loaded DC vaccine stimulate the immune system to kill tumor cells and extend survival in patients with glioblastoma.
    Location: Duke University Medical Center, Durham, North Carolina