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Last Updated: June 28, 2022

CLINICAL TRIALS PROFILE FOR GLEOSTINE


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All Clinical Trials for Gleostine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01989052 ↗ Ph 1/2 CTO With Lomustine for Bevacizumab-Naive Recurrent Glioma Terminated Tactical Therapeutics, Inc. Phase 1 2014-05-01 This is a Phase 1/2 study of the combination of CTO with lomustine in patients with recurrent malignant glioma to be treated at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke. The Primary Objectives are: - Phase 1: To determine the maximum tolerated dose (MTD) of CTO when combined with lomustine among patients with recurrent malignant glioma (World Health Organization (WHO) grade III or IV) who have not been previously treated with bevacizumab. - Phase 2: To assess the efficacy of CTO (either in monotherapy or in combination with lomustine) compared to lomustine alone in patients with recurrent WHO grade IV malignant gliomas that have not been previously treated with bevacizumab based upon 6-month progression free survival (PFS6). Note: This study was terminated early due to funding issues. At the time of termination, the study was still in Phase 1 and no MTD for the combination of CTO and lomustine had been determined for this population. Phase 2 will not proceed.
NCT01989052 ↗ Ph 1/2 CTO With Lomustine for Bevacizumab-Naive Recurrent Glioma Terminated Annick Desjardins Phase 1 2014-05-01 This is a Phase 1/2 study of the combination of CTO with lomustine in patients with recurrent malignant glioma to be treated at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke. The Primary Objectives are: - Phase 1: To determine the maximum tolerated dose (MTD) of CTO when combined with lomustine among patients with recurrent malignant glioma (World Health Organization (WHO) grade III or IV) who have not been previously treated with bevacizumab. - Phase 2: To assess the efficacy of CTO (either in monotherapy or in combination with lomustine) compared to lomustine alone in patients with recurrent WHO grade IV malignant gliomas that have not been previously treated with bevacizumab based upon 6-month progression free survival (PFS6). Note: This study was terminated early due to funding issues. At the time of termination, the study was still in Phase 1 and no MTD for the combination of CTO and lomustine had been determined for this population. Phase 2 will not proceed.
NCT02343406 ↗ Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas Completed European Organisation for Research and Treatment of Cancer - EORTC Phase 2 2015-02-17 This study was conducted to evaluate the efficacy and safety of depatuxizumab mafodotin (ABT-414) alone or with temozolomide versus temozolomide or lomustine alone in adult participants with recurrent glioblastoma. The study also included a substudy to evaluate safety, tolerability and pharmacokinetics of ABT-414 in a pediatric population.
NCT02343406 ↗ Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas Completed AbbVie Phase 2 2015-02-17 This study was conducted to evaluate the efficacy and safety of depatuxizumab mafodotin (ABT-414) alone or with temozolomide versus temozolomide or lomustine alone in adult participants with recurrent glioblastoma. The study also included a substudy to evaluate safety, tolerability and pharmacokinetics of ABT-414 in a pediatric population.
NCT02724579 ↗ Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients With Newly Diagnosed WNT-Driven Medulloblastoma Recruiting National Cancer Institute (NCI) Phase 2 2017-10-02 This phase II trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using chemotherapy and radiation therapy have been shown to be effective in treating patients with WNT-driven medulloblastoma. However, there is a concern about the late side effects of treatment, such as learning difficulties, lower amounts of hormones, or other problems in performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine sulfate, cyclophosphamide and lomustine, 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 reduced craniospinal radiation therapy and chemotherapy may kill tumor cells and may also reduce the late side effects of treatment.
NCT02724579 ↗ Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients With Newly Diagnosed WNT-Driven Medulloblastoma Recruiting Children's Oncology Group Phase 2 2017-10-02 This phase II trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using chemotherapy and radiation therapy have been shown to be effective in treating patients with WNT-driven medulloblastoma. However, there is a concern about the late side effects of treatment, such as learning difficulties, lower amounts of hormones, or other problems in performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine sulfate, cyclophosphamide and lomustine, 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 reduced craniospinal radiation therapy and chemotherapy may kill tumor cells and may also reduce the late side effects of treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Gleostine

Condition Name

Condition Name for Gleostine
Intervention Trials
Glioblastoma 5
Anaplastic Astrocytoma 2
Recurrent Glioblastoma 2
Malignant Glioma 2
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Condition MeSH

Condition MeSH for Gleostine
Intervention Trials
Glioblastoma 8
Glioma 4
Gliosarcoma 2
Neoplasms 2
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Clinical Trial Locations for Gleostine

Trials by Country

Trials by Country for Gleostine
Location Trials
United States 142
Canada 16
Australia 9
Belgium 9
Germany 9
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Trials by US State

Trials by US State for Gleostine
Location Trials
Washington 6
California 6
North Carolina 6
Georgia 6
Texas 6
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Clinical Trial Progress for Gleostine

Clinical Trial Phase

Clinical Trial Phase for Gleostine
Clinical Trial Phase Trials
Phase 3 2
Phase 2/Phase 3 1
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for Gleostine
Clinical Trial Phase Trials
Recruiting 5
Not yet recruiting 4
Completed 2
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Clinical Trial Sponsors for Gleostine

Sponsor Name

Sponsor Name for Gleostine
Sponsor Trials
National Cancer Institute (NCI) 3
CNS Pharmaceuticals, Inc. 1
Darell D. Bigner, MD, PhD 1
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Sponsor Type

Sponsor Type for Gleostine
Sponsor Trials
Other 11
Industry 9
NIH 3
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Serving leading biopharmaceutical companies globally:

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