Poly-ICLC in Treating Patients With Recurrent or Progressive Anaplastic Glioma

• Status: Completed
• Trial end date: 2009-01-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboxymethylcellulose Sodium; Poly I-C; Poly ICLC

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