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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00052650 |
Purpose
RATIONALE: Biological therapies such as PEG-interferon alfa-2b use different ways to stimulate the immune system and stop cancer cells from growing. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if PEG-interferon alfa-2b is more effective with or without thalidomide in treating recurrent high-grade gliomas.
PURPOSE: This phase II trial to study the effectiveness of PEG-interferon alfa-2b and thalidomide in treating patients who have recurrent high-grade gliomas.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Biological: PEG-interferon alfa-2b Drug: thalidomide Procedure: adjuvant therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Active Control |
| Official Title: | A Phase II Study Of Peginterferon Alpha-2B (PEG-INTRON) And Thalidomide In Adults With Recurrent High Grade Gliomas |
| Estimated Enrollment: | 64 |
| Study Start Date: | March 2004 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to type of glioma (glioblastoma multiforme vs anaplastic glioma).
Patients receive PEG-interferon alfa-2b subcutaneously once weekly and oral thalidomide once daily for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 64 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed supratentorial malignant primary gliomas including the following:
Recurrent disease
Measurable or evaluable disease with evidence of tumor recurrence or progression by MRI or CT scan
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
At least 4 weeks since prior cytotoxic therapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | Howard A. Fine, MD | NCI - Neuro-Oncology Branch |
More Information
| Responsible Party: | NCI - Neuro-Oncology Branch ( Howard A. Fine ) |
| Study ID Numbers: | CDR0000258609, NCI-03-C-0002, NABTC-0201 |
| Study First Received: | January 24, 2003 |
| Last Updated: | April 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00052650 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma |
adult brain stem glioma adult mixed glioma adult giant cell glioblastoma adult gliosarcoma |
|
Anti-Infective Agents Thalidomide Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue 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 |
Interferon-alpha Neoplasms by Histologic Type Growth Substances Nervous System Diseases Interferons Immunosuppressive Agents Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neuroectodermal Tumors Neoplasms Peginterferon alfa-2b Neoplasms, Neuroepithelial Interferon Alfa-2a Interferon Alfa-2b |