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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: | NCT00058123 |
RATIONALE: Biological therapies such as poly-ICLC use different ways to stimulate the immune system and stop tumor cells from growing.
PURPOSE: This phase II trial is studying how poly-ICLC works in treating patients with recurrent, progressive, or relapsed anaplastic glioma.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: poly ICLC |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Poly ICLC in Patients With Recurrent Anaplastic Glioma |
Estimated Enrollment: | 46 |
Study Start Date: | March 2003 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive poly ICLC intramuscularly 3 times a week for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 22-46 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 intracranial anaplastic glioma, including any of the following subtypes:
Prior radiotherapy required
Relapsed disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
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 Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 | |
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, Pennsylvania | |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
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 Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-6164 |
Study Chair: | Susan M. Chang, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000287012, NABTC-0106 |
Study First Received: | April 7, 2003 |
Last Updated: | November 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00058123 |
Health Authority: | United States: Federal Government |
adult anaplastic astrocytoma adult mixed glioma adult anaplastic oligodendroglioma recurrent adult brain tumor adult anaplastic ependymoma |
Astrocytoma Interferons Poly ICLC Central Nervous System Neoplasms Ependymoma Recurrence Brain Neoplasms |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroepithelioma Oligodendroglioma Glioma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Interferon Inducers Neoplasms Neoplasms by Site Neoplasms by Histologic Type Immunologic Factors |
Physiological Effects of Drugs Nervous System Diseases Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Pharmacologic Actions |