Poly-ICLC in Treating Patients With Recurrent or Progressive Anaplastic Glioma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Intervention: poly ICLC
Intervention MeSH terms: Poly ICLC
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adult anaplastic astrocytoma; adult mixed glioma; adult anaplastic oligodendroglioma; recurrent adult brain tumor; adult anaplastic ependymoma

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.
    

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