poly-iclc in treating patients with recurrent or progressive anaplastic glioma

Conditions: Brain and Central Nervous System Tumors

Summary: 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.

objectives: * determine the objective response rate in patients with recurrent or progressive anaplastic glioma treated with poly iclc. * determine the efficacy of this drug, in terms of 6-month progression-free survival, in these patients. * determine the safety profile of this drug in these patients. * determine the survival of patients treated with this drug. * determine the tumor response rate in patients treated with this drug. * determine the biological effects of this drug in these patients. 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.

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

Keywords: adult anaplastic astrocytoma adult mixed glioma adult anaplastic oligodendroglioma recurrent adult brain tumor adult anaplastic ependymoma