Poly-ICLC in Treating Patients With Recurrent or Progressive Anaplastic Glioma
Brain and Central Nervous System Tumors
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult anaplastic astrocytoma, adult mixed glioma, adult anaplastic oligodendroglioma, recurrent adult brain tumor, adult anaplastic ependymoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed intracranial anaplastic glioma, including any of the following subtypes: Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Other anaplastic gliomas NOTE: Patients with an original histology of low-grade glioma are allowed provided a subsequent histological diagnosis of an anaplastic glioma is made Must have evidence of tumor recurrence or progression by MRI or CT scan* NOTE: *Steroid dose must be stable for at least 5 days before scan Prior radiotherapy required Patients who have had prior interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis by positron-emission tomography, thallium scanning, magnetic resonance spectroscopy, or surgical documentation of disease Relapsed disease Progression after initial therapy (e.g., radiotherapy with or without chemotherapy) No more than 3 prior therapies (initial therapy and treatment for no more than 2 prior relapses) Surgical resection for relapsed disease with no anticancer therapy for up to 12 weeks followed by another surgical resection is considered 1 relapse For patients who have had prior therapy for a low-grade glioma, the surgical diagnosis of high-grade glioma is considered the first relapse Must be registered in the North American Brain Tumor Consortium Data Management Center database PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy More than 8 weeks Hematopoietic WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic Bilirubin less than 2 times upper limit of normal (ULN) SGOT less than 2 times ULN Renal Creatinine less than 1.5 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other cancer within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No active infection No concurrent serious medical illness No significant medical illness that cannot be adequately controlled with therapy or that would preclude tolerability of study drug No disease that would obscure toxicity or dangerously alter drug metabolism PRIOR CONCURRENT THERAPY: Biologic therapy At least 1 week since prior interferon or thalidomide No prior poly ICLC Chemotherapy See Disease Characteristics At least 2 weeks since prior vincristine At least 3 weeks since prior procarbazine At least 6 weeks since prior nitrosoureas No concurrent chemotherapy Endocrine therapy See Disease Characteristics At least 1 week since prior tamoxifen Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery See Disease Characteristics Other Recovered from all prior therapy At least 1 week since other prior noncytotoxic agents (e.g., isotretinoin), excluding radiosensitizers At least 4 weeks since prior cytotoxic therapy At least 4 weeks since prior investigational agents
Sites / Locations
- Jonsson Comprehensive Cancer Center at UCLA
- UCSF Comprehensive Cancer Center
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- Memorial Sloan-Kettering Cancer Center
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
- M.D. Anderson Cancer Center at University of Texas
- University of Texas Health Science Center at San Antonio
- University of Wisconsin Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Poly-ICLC Recurrent gliomas
Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday) Intramuscular injection Drug Poly-ICLC