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 51-75 of 83

  • OKN-007 and Temozolomide in Treating Patients with Grade III-IV Glioblastoma Multiforme Undergoing Adjuvant Concomitant Radiotherapy

    This early phase I trial studies the side effects of OKN-007 and temozolomide in treating patients with grade III-IV glioblastoma multiforme undergoing concomitant radiotherapy after surgery. OKN-007 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 OKN-007 and temozolomide chemo-radiotherapy may work better in treating patients with glioblastoma multiforme after surgery.
    Location: University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma

  • M7824 and Topotecan or Temozolomide in Relapsed Small Cell Lung Cancers

    BACKGROUND: - Small cell lung cancer (SCLC) is an aggressive cancer with a poor prognosis. Although highly responsive to chemotherapy initially, SCLC relapses quickly and becomes refractory to treatment within a few months. - The inability to destroy residual SCLC cells despite initial chemosensitivity suggests the existence of a highly effective DNA damage response network. SCLC is also characterized by high DNA replication stress (RB1 inactivation, MYC and CCNE1 activation). - There is only one FDA approved treatment for patients with relapsed SCLC after first-line chemotherapy: topotecan, which inhibits religation of topoisomerase I-mediated single-strand DNA breaks leading to lethal double-strand DNA breaks. Temozolomide, an oral alkylating agent, which causes DNA damage by alkylating guanine at position O6 also has activity in relapsed SCLC, particularly for brain metastases. - Preliminary evidence indicates that disruption of the immune checkpoint PD-1 / PD-L1 pathway can yield responses in a subset of SCLC patients, but response rates (approximately equal to 10%) are lower than NSCLC and other tumors with comparable tumor mutational burden indicating additional immunosuppressive mechanisms at play in the SCLC tumor microenvironment. - M7824 is a bifunctional fusion protein consisting of an anti-programmed death ligand 1 (PDL1) antibody and the extracellular domain of transforming growth factor beta (TGF-beta) receptor type 2, a TGF-beta trap. - Safety data from the dose-escalation study in solid tumors as well as preliminary data from expansion cohorts show that M7824 has a safety profile similar to other checkpoint inhibiting compounds. - Combining immunotherapy, and chemotherapy could synergistically improve the anticancer activity of immunotherapy. Combination of chemotherapy with immunotherapy have improved outcomes in NSCLC and melanoma leading to FDA approvals of such combinations. - We hypothesize that increased DNA damage induced by topotecan and temozolomide will complement the anti-tumor activity of M7824, in recurrent SCLC. OBJECTIVE: - The primary objective of the trial is to determine the efficacy (using objective response rate) of M7824 plus topotecan or temozolomide in relapsed SCLC. ELIGIBILITY: - Subjects with histological or cytological confirmation of SCLC. - Subjects must be greater than or equal to 18 years of age and have a performance status (ECOG) less than or equal to 2. - Subjects must not have received chemotherapy, or undergone major surgery within 2 weeks and radiotherapy within 24 hours prior to enrollment. - Subjects must have adequate organ function and measurable disease. DESIGN: - Arm A (M7824 monotherapy): Up to 10 patients may be treated with M7824 monotherapy to obtain safety and PK data, and a preliminary estimate of clinical responses to M7824 in SCLC. Patients with progressive disease on Arm A may then receive M7824 plus temozolomide as per description of treatment for Arm C. - Arm B (M7824 plus topotecan) and Arm C (M7824 plus temozolomide) will be administered in 3 and 4-week cycles respectively; these arms will have a safety run-in followed by efficacy analysis. Up to 10 patients with extrapulmonary small cell cancer will be enrolled in arm C to receive the combination of M7824 and temozolomide. - Optional tumor biopsies will be obtained at pre-treatment on C1D1 and C1D15 for Arm C; pre-treatment on C1D1 and C2D1 for arms A and B. - Every subject of each arm of the safety run-in will be observed for at least 7 days after first dose of M7824 before the subsequent subject can be treated. Subjects who are not evaluable for DLT will be replaced and not included into evaluation ARMS: - Arm A (3-week cycles): M7824 monotherapy 2400 mg every 3 weeks until disease progression or a criterion in Protocol is met. Patients with progressive disease on Arm A may then receive 1200 mg M7824 every 2 weeks plus temozolomide 200 mg / m^2 / day on days 1-5 every 4 weeks. - Arm B (3-week cycles): M7824 2400 mg plus topotecan 1 mg / m2 on days 1-5 every 3 weeks until disease progression or a criterion in Protocol is met. - Arm C (4-week cycles): M7824 1200 mg every 2 weeks plus temozolomide 200 mg / m2 / day on days 1-5 every 4 weeks until disease progression or a criterion in Protocol
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Ibrutinib and Radiation Therapy with or without Temozolomide in Treating Participants with Newly Diagnosed Methylated or Unmethylated Glioblastoma

    This phase I trial studies the best dose of ibrutinib when given together with radiation therapy radiation and with or without temozolomide in treating participants with newly diagnosed methylated or unmethylated glioblastoma. Ibrutinib 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. It is not yet known whether giving ibrutinib and radiation therapy with or without temozolomide may work better in treating glioblastoma.
    Location: Case Comprehensive Cancer Center, Cleveland, Ohio

  • Ruxolitinib and Radiation Therapy with or without Temozolomide in Treating Patients with Newly Diagnosed Grade III Glioma or Glioblastoma

    This phase I trial studies the best dose and side effects of ruxolitinib when given together with radiation therapy with or without temozolomide, and to see how well they work in treating patients with newly diagnosed grade III glioma or glioblastoma. Ruxolitinib 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. Temozolomide works by damaging the deoxyribonucleic acid (DNA) of tumor cells so that they cannot divide properly. Giving ruxolitinib and radiation therapy with or without temozolomide may work better in treating patients with grade III glioma or glioblastoma.
    Location: Case Comprehensive Cancer Center, Cleveland, Ohio

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

    This phase I trial studies the side effects and best dose of vorinostat when given together with pembrolizumab, temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma. 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. Drugs used in chemotherapy, such as vorinostat and 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab, vorinostat and temozolomide with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.
    Location: Moffitt Cancer Center, Tampa, Florida

  • EGFR Bispecific Antibody Armed T cells in Combination with Radiation Therapy and Temozolomide in Treating Participants with Newly Diagnosed Glioblastoma

    This phase I trial studies the side effects and best dose of EGFR bi-armed autologous T cells in combination with radiation therapy and temozolomide in treating participants with newly diagnosed glioblastoma. EGFR bi-armed autologous T cells target the EGFR molecules on glioblastoma tumor cells and use the body's own immune system to destroy those tumor cells. 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 EGFR bi-armed autologous T cells with radiation therapy and temozolomide may work better in treating participants with newly diagnosed glioblastoma.
    Location: University of Virginia Cancer Center, Charlottesville, Virginia

  • Pembrolizumab and Standard Therapy in Treating Patients with Glioblastoma

    This phase II trial studies the side effects and how well pembrolizumab works in combination with standard therapy in treating patients with glioblastoma. 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. Drugs used in the 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 uses high energy beams to kill tumor cells and shrink tumors. Giving pembrolizumab and standard therapy comprising of temozolomide and radiation therapy may kill tumor cells.
    Location: Mayo Clinic in Rochester, Rochester, Minnesota

  • T-DM1 Alone Versus T-DM1 and Metronomic Temozolomide in Secondary Prevention of HER2-Positive Breast Cancer Brain Metastases Following Stereotactic Radiosurgery

    Background: Sometimes breast cancer spreads (metastasizes) to the brain. Researchers want to study new treatments for brain metastases. The drug Temozolomide is approved to treat brain tumors. Researchers want to see if combining it with the drug T-DMI prevents the formation of new metastases in the brain. Objective: To study if Temozolomide with T-DM1 lowers the chance of having new metastases in the brain. Eligibility: Adults at least 18 years old with a HER2-positive breast cancer that has spread to the brain and was recently treated with stereotactic radiation or surgery. Design: Participants will be screened with - Medical history - Physical exam - Heart tests - A scan (CT) that makes a picture of the body using a small amount of radiation - A scan (MRI) that uses a magnetic field to make an image of the brain - Blood tests. - Pregnancy test. The study will be done in 3-week cycles. All participants will get T-DM1 on Day 1 of every cycle through a small plastic tube inserted in an arm vein. Some participants will also take Temozolomide capsules by mouth every day. Participants will keep a medication diary. During the study, participants will also: - Repeat most of the screening tests. - Answer questions about their general well-being and functioning. Participants will have lumbar puncture at least 2 times. A needle is inserted into the spinal canal low in the back and cerebrospinal fluid is collected. This will be done with local anesthesia and with the help of images. Participants will be asked to provide tumor samples when available. Participants will have a follow-up visit about 1 month after stopping the study drug. They will be contacted by telephone or email every 3 months after that.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Expedited Laser Interstitial Thermal Therapy, Radiation Therapy, and Temozolomide in Treating Patients with Newly Diagnosed High Grade Glioma

    This phase 0 trial studies the side effects and how well shortening the time between laser interstitial thermal therapy, radiation therapy, and temozolomide works in treating patients with newly diagnosed high grade glioma. Laser interstitial thermal therapy uses a laser to kill tumor cells by heating them. 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. Shortening the time between laser interstitial thermal therapy, radiation therapy, and temozolomide may kill tumor cells more effectively in patients with high grade glioma.
    Location: Case Comprehensive Cancer Center, Cleveland, Ohio

  • TAS-102 and Temozolomide in Treating Patients with Metastatic Neuroendocrine Tumors

    This phase IB trial studies the side effects and best dose of temozolomide when given together with trifluridine and tipiracil hydrochloride (TAS-102) and to see how well they work in treating patients with neuroendocrine tumors that have spread to other places in the body (metastatic). Drugs used in chemotherapy, such as TAS-102 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.
    Location: University of Wisconsin Hospital and Clinics, Madison, Wisconsin

  • Temozolomide Chronotherapy in Treating Patients with High Grade Glioma

    This phase II trial studies how well temozolomide chronotherapy works in treating patients with high grade glioma. Chronotherapy is the treatment of an illness according to the timing of biological rhythms within a patient. 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 time of day that temozolomide is given may reduce side effects and increase anti-tumor activity in patients with high grade glioma.
    Location: Siteman Cancer Center at Washington University, Saint Louis, Missouri

  • Disulfiram and Copper Gluconate with Radiation Therapy and Temozolomide in Treating Patients with Newly Diagnosed Glioblastoma That Can Be Removed by Surgery

    This phase I / II trial studies the side effects and best dose of disulfiram when given together with copper gluconate, radiation therapy, and temozolomide and to see how well they work in treating patients with newly diagnosed glioblastoma that can be removed by surgery. Disulfiram may reduce tumor growth by blocking the activity necessary for tumor growth. Copper gluconate is a dietary supplement that may help disulfiram work better by making the tumor cells more sensitive to the drug. Giving disulfiram and copper gluconate together with radiation therapy and temozolomide may work better in treating patients with glioblastoma.
    Location: Siteman Cancer Center at Washington University, Saint Louis, Missouri

  • Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme

    The purpose of this research study is to determine if an investigational dendritic cell vaccine, called pp65 DC, is effective for the treatment of a specific type of brain tumor called glioblastoma (GBM) when given with stronger doses of routine chemotherapy.
    Location: Duke University Medical Center, Durham, North Carolina

  • Vaccine Therapy and Temozolomide in Treating Patients with Recurrent Glioma Expressing IDH1

    This phase I trial studies the side effects of vaccine therapy and temozolomide in treating patients with glioma expressing isocitrate dehydrogenase 1 (IDH1) gene that has returned (come back) after a period of improvement (recurrent). Vaccines made from peptides may help the body build an effective immune response to kill tumor cells that express IDH1. 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 vaccine therapy with temozolomide may be a better treatment for recurrent glioma.
    Location: Duke University Medical Center, Durham, North Carolina

  • A Study of Abemaciclib (LY2835219) in Combination With Temozolomide and Irinotecan and Abemaciclib in Combination With Temozolomide in Children and Young Adult Participants With Solid Tumors

    The study's purpose is to see if the drug abemaciclib is safe and effective in combination with temozolomide and irinotecan (Part A) and abemaciclib in combination with temozolomide (Part B) in pediatric and young adult participants with relapsed / refractory solid tumors.
    Location: Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

  • AQ4N in Combination With Radiotherapy and Temozolomide in Subjects With Newly Diagnosed Glioblastoma Multiforme

    Phase 1b of the study, will evaluate the safety and tolerability of AQ4N treatment at three different dose levels. Phase 2a of the study, will further evaluate the safety, tolerability, and in addition efficacy of AQ4N treatment at a tolerated dose selected from Phase 1b.
    Location: See Clinical Trials.gov

  • Study of Tislelizumab and / or Pamiparib Containing Treatments in Participants With Advanced Malignancies

    This is an open-label, multicenter, extension study to evaluate the long-term safety of tislelizumab or pamiparib given either as monotherapy or in combination with each other or with other agents in participants with advanced malignancies who participated in a prior BeiGene sponsored clinical study (parent study).
    Location: See Clinical Trials.gov

  • Vincristine and Temozolomide in Combination With PEN-866 for Adolescents and Young Adults With Relapsed or Refractory Solid Tumors

    Background: The drug PEN-866 can remain in tumor cells longer than it does in normal cells. It also may be more effective than other drugs at treating Ewing sarcoma and rhabdomyosarcoma. Researchers want to learn if combining PEN-866 with other drugs can treat certain cancers in adolescents and young adults. Objective: To learn if the combination of PEN-866 with vincristine and temozolomide can be used to treat adolescents and young adults with solid tumors that have returned after or did not respond to standard treatments, or for which there are no standard treatments. Eligibility: People ages 12-39 years who have solid tumors, Ewing sarcoma, or rhabdomyosarcoma that returned after or did not respond to standard treatments. Design: Participants will be screened with a medical history, physical exam, and eye exam. They will have heart function tests. They may have imaging scans of the chest, abdomen, and pelvis. They will give blood and urine samples. They may have a tumor biopsy. Some samples will be used for genetic testing. Some screening tests will be repeated during the study. Participants will get 3 drugs for up to 18 cycles. Each cycle lasts 21 days. They will get PEN-866 and vincristine by IV infusion (a tube in their vein) on Days 1 and 8 of each cycle. They will take temozolomide by mouth on Days 1-5 of each cycle. Participants will complete questionnaires about their physical, mental, and social health. Participants will have a follow-up visit 30 days after treatment ends. They may be contacted by phone or email for the rest of their life.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Association of Peripheral Blood Immunologic Response to Therapeutic Response to Adjuvant Treatment With Immune Checkpoint Inhibition (ICI) in Patients With Newly Diagnosed Glioblastoma or Gliosarcoma

    Background: Glioblastoma (GBM) is a type of malignant glioma. These cancers are nearly always fatal. People who develop these cancers get aggressive treatments. But the tumors almost always recur. Researchers want to study people with newly diagnosed disease to learn more. Objective: To study people with newly diagnosed GBM or gliosarcoma to look at the changes in immune cells in the blood of those who take ipilimumab and nivolumab, along with temozolomide. Eligibility: Adults ages 18 and older with newly diagnosed GBM or gliosarcoma, who have had surgical removal of their tumor and have completed standard initial chemotherapy and radiation therapy. Design: Participants will be screened with the following: Medical record review Medical history Physical exam Tests to assess their nervous system and their ability to do typical activities Blood tests Tumor assessment. For this, they will have magnetic resonance imaging (MRI). They may get a contrast dye through an intravenous (IV) catheter. The MRI scanner makes noise. They will get earplugs. Electrocardiogram. It measures heart rate and rhythm. They will lie still. Sticky pads will be placed on their chest, arms, and legs. Screening tests will be repeated during the study. Treatment will be given in cycles. Each cycle lasts 4 weeks. Participants will get nivolumab and ipilimumab via IV. They will take temozolomide by mouth. They will keep a pill diary. Participants will fill out surveys about their symptoms. Participants will have follow-up visits about 60 days and 100 days after treatment ends. Then they will be contacted every 6 months for the rest of their life.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Pamiparib and Temozolomide for the Treatment of Hereditary Leiomyomatosis and Renal Cell Cancer

    This phase II trial investigates how well pamiparib and temozolomide work in treating patients with hereditary leiomyomatosis and renal cell (kidney) cancer. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as pamiparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. 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 pamiparib and temozolomide may help treat patients with hereditary leiomyomatosis and renal cell cancer.
    Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California

  • Testing a New Anti-Cancer Drug, 131I-Omburtamab, in Recurrent Medulloblastoma or Ependymoma

    This phase II trial studies the effect of 131I-omburtamab compared to usual chemotherapy in treating patients with medulloblastoma that has come back (recurrent) (Stratum 1), and the effect of 131I-omburtamab in treating patients with recurrent ependymoma (Stratum 2). Patients in both strata receive 131I-omburtamab, a monoclonal antibody called 8H9 linked to a radioactive agent called iodine 131. 8H9 attaches to B7H3 positive tumor cells in a targeted way and delivers iodine 131 to kill them. Patients in Stratum 1 receive the usual chemotherapy drugs, temozolomide and irinotecan, that 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. Patients in Stratum 1 also receive the usual drug bevacizumab, which may stop or slow tumor cells by blocking the growth of new blood vessels necessary for tumor growth. Adding a new drug called 131I-omburtamab to the usual chemotherapy may lower the chance of recurrent medulloblastoma growing or spreading (Stratum 1). Giving 131I-omburtamab may also be used safely to treat patients with recurrent ependymoma (Stratum 2).
    Location: Location information is not yet available.

  • Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 2

    The primary objectives of this study are to determine the maximal tolerated dose (MTD) of PAC-1 in combination with temozolomide in patients with high grade glioma: glioblastoma multiforme (GBM) or anaplastic astrocytoma after progression following standard first line therapy (Component 2), by evaluation of toxicity and tolerability.
    Location: Johns Hopkins University / Sidney Kimmel Cancer Center, Baltimore, Maryland

  • 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: 118 locations

  • Temozolomide, Radiation Therapy, and Tumor Treating Fields Therapy in Treating Participants with Glioblastoma

    This pilot early phase I trial studies the side effects of temozolomide, radiation therapy, and tumor treating fields therapy using Novo tumor treatment fields (TTF)-100A device in participants with glioblastoma. 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 uses high energy x-rays to kill tumor cells and shrink tumors. NovoTTF-100A device is a portable device that produces alternating electrical fields that may disrupt growth of cancer cells. Giving temozolomide, radiation therapy, and tumor treating fields therapy using NovoTTF-100A device may work better in treating participants with glioblastoma.
    Location: Thomas Jefferson University Hospital, Philadelphia, Pennsylvania

  • Atezolizumab in Combination with Temozolomide and Radiation Therapy in Treating Patients with Newly Diagnosed Glioblastoma

    This phase I / II trial studies the side effects and how well atezolizumab works in combination with temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma. 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. 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 uses high energy beams to kill tumor cells and shrink tumors. It is not yet known how well atezolizumab works in combination with temozolomide and radiation therapy in treating patients with glioblastoma.
    Location: M D Anderson Cancer Center, Houston, Texas