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Sponsors and Collaborators: |
Norris Cotton Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00039468 |
RATIONALE: Thalidomide may stop the growth of glioblastoma multiforme by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with irinotecan may kill any tumor cells remaining after radiation therapy.
PURPOSE: Phase II trial to study the effectiveness of combining thalidomide with irinotecan in treating patients who have glioblastoma multiforme that has been treated with radiation therapy.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: irinotecan hydrochloride Drug: thalidomide Procedure: adjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study Of Thalidomide And CPT-11 (IRINOTECAN) Following Radiotherapy For Glioblastoma Multiforme |
Study Start Date: | March 2002 |
OBJECTIVES:
OUTLINE: Beginning 2-4 weeks after completion of radiotherapy, patients receive irinotecan IV over 90 minutes on day 1. Patients also receive oral thalidomide daily. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, 1 week after the first course, prior to all subsequent courses, and then after course 6.
Patients are followed for 5 years.
PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed glioblastoma multiforme (GBM)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
No concurrent cytochrome P450 inhibitors, including the following:
United States, New Hampshire | |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
Lebanon, New Hampshire, United States, 03756-0002 | |
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |
Columbus, Ohio, United States, 43210-1240 |
Study Chair: | Camilo E. Fadul, MD | Norris Cotton Cancer Center |
Study ID Numbers: | CDR0000069386, DMS-0134, DMS-15615, NCI-G02-2078 |
Study First Received: | June 6, 2002 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00039468 History of Changes |
Health Authority: | United States: Federal Government |
adult glioblastoma recurrent adult brain tumor adult giant cell glioblastoma adult gliosarcoma |
Anti-Infective Agents Glioblastoma Immunologic Factors Thalidomide Astrocytoma Irinotecan Adjuvants, Immunologic Central Nervous System Neoplasms Angiogenesis Inhibitors Immunosuppressive Agents Camptothecin Recurrence |
Anti-Bacterial Agents Brain Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Glioblastoma Multiforme Gliosarcoma Antineoplastic Agents, Phytogenic Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Glioblastoma Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Thalidomide Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Irinotecan Physiological Effects of Drugs Central Nervous System Neoplasms Anti-Bacterial Agents Neoplasms by Site Neoplasms, Germ Cell and Embryonal Therapeutic Uses Growth Inhibitors |
Angiogenesis Modulating Agents Glioma Nervous System Neoplasms Neoplasms by Histologic Type Astrocytoma Growth Substances Nervous System Diseases Enzyme Inhibitors Angiogenesis Inhibitors Immunosuppressive Agents Camptothecin Pharmacologic Actions Neuroectodermal Tumors Neoplasms Neoplasms, Neuroepithelial |