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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005976 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of pyrazoloacridine plus carboplatin in treating patients who have recurrent glioma.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: carboplatin Drug: pyrazoloacridine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I/II Trial of Pyrazoloacridine and Carboplatin in Patients With Recurrent Glioma |
Study Start Date: | May 2000 |
OBJECTIVES:
OUTLINE: This is a three-part, dose-escalation, multicenter study. Patients in study 3 are stratified according to concurrent anticonvulsants (yes vs no).
Cohorts of 3-6 patients receive escalating doses of carboplatin and pyrazoloacridine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years.
PROJECTED ACCRUAL: Study 1: (Study 1 closed as of 03/29/02)
Study 3:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary brain glioma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Study 3 only:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study 1 only: (Study 1 closed as of 03/29/02)
Study 2 only: (Study 2 closed as of 03/29/02)
Study Chair: | Evanthia Galanis, MD | Mayo Clinic |
Study ID Numbers: | CDR0000067963, NCCTG-987254 |
Study First Received: | July 5, 2000 |
Last Updated: | November 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00005976 |
Health Authority: | United States: Federal Government |
recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma |
adult mixed glioma adult oligodendroglioma adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Astrocytoma Carboplatin Central Nervous System Neoplasms Recurrence Brain Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
NSC 366140 Neuroepithelioma Oligodendroglioma Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses |
Nervous System Diseases Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Pharmacologic Actions |