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Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
This study is currently recruiting patients.
Sponsored by: | North American Brain Tumor Consortium |
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Information provided by: | National Cancer Institute (NCI) |
Purpose
RATIONALE: Biological therapies such as poly-ICLC use different ways to stimulate the immune system and stop tumor cells from growing. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining biological therapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining poly-ICLC with radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.
Condition | Treatment or Intervention | Phase |
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adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Drug: poly ICLC Procedure: biological response modifier therapy Procedure: non-specific immune-modulator therapy Procedure: radiation therapy |
Phase II |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Poly-ICLC and Radiotherapy in Patients With Newly Diagnosed Glioblastoma Multiforme
OBJECTIVES:
OUTLINE: This is a multicenter study.
Within 1-4 weeks after surgery, patients receive poly ICLC intramuscularly 3 times weekly (on days 1, 3, and 5). Treatment continues in the absence of disease progression or unacceptable toxicity.
One week after the initiation of poly ICLC, patients undergo external beam radiotherapy once daily 5 days a week for 6 weeks.
Patients are followed monthly for 1 year and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Location and Contact Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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