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Sponsors and Collaborators: |
North American Brain Tumor Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00085540 |
RATIONALE: FR901228 may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase I/II trial is studying the side effects and best dose of FR901228 and to see how well it works in treating patients with recurrent high-grade gliomas.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: romidepsin |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I-II Trial of Depsipeptide in Patients With Recurrent High-Grade Gliomas |
Estimated Enrollment: | 80 |
Study Start Date: | July 2004 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group B (phase I): Experimental
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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Drug: romidepsin
Given IV
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Group A (phase II): Experimental
Patients receive FR901228 as in phase I at dose level 1.
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Drug: romidepsin
Given IV
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Group B (phase II): Experimental
Patients receive FR901228 as in phase I at the MTD.
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Drug: romidepsin
Given IV
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OBJECTIVES:
Phase I
Phase II
OUTLINE: This is a multicenter, phase I, dose-escalation study followed by a phase II study. Patients are stratified according to study phase (I vs II), concurrent use of enzyme-inducing anti-epileptic drugs (EIAEDs) (yes vs no), histology (recurrent glioblastoma multiforme/gliosarcoma vs recurrent anaplastic glioma), pre-operative candidacy (yes vs no), and measurable/evaluable disease (yes vs no). Patients are assigned to 1 of 2 treatment groups (group A: no EIAEDs or group B: concurrent use of EIAEDs).
Cohorts of 3-6 patients receive escalating doses of FR901228 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of up to 6 patients experience dose-limiting toxicity.
Phase II (groups A and B):
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for the phase I portion of this study within 8 months. A total of 50 patients (32 with recurrent glioblastoma multiforme and 18 with recurrent anaplastic gliomas) will be accrued to the phase II portion of this study within 6-8 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Phase I and phase II:
Histologically confirmed recurrent intracranial malignant glioma, including any of the following:
No more than 2 prior therapies (initial treatment and treatment for 1 relapse)*
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
Fertile patients must use effective barrier contraception during and for at least 2 weeks after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095-1781 | |
UCSF Helen Diller Family Comprehensive Cancer Center | |
San Francisco, California, United States, 94143 | |
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
Memorial Sloan - Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 | |
United States, Pennsylvania | |
UPMC Cancer Centers | |
Pittsburgh, Pennsylvania, United States, 15232 | |
United States, Texas | |
M. D. Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4009 | |
University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78284-6220 | |
United States, Wisconsin | |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-6164 |
Study Chair: | Howard A. Fine, MD | NCI - Neuro-Oncology Branch |
Study ID Numbers: | CDR0000370817, NABTC-0303, NCI-05-C-0098 |
Study First Received: | June 10, 2004 |
Last Updated: | December 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00085540 |
Health Authority: | United States: Food and Drug Administration |
recurrent adult brain tumor adult anaplastic oligodendroglioma adult anaplastic astrocytoma |
adult mixed glioma adult gliosarcoma adult giant cell glioblastoma |
Glioblastoma Astrocytoma Romidepsin Central Nervous System Neoplasms Recurrence Brain Neoplasms Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal 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 Antibiotics, Antineoplastic Neoplasms, Neuroepithelial Pharmacologic Actions |