RATIONALE: Biological therapies such as PEG-interferon alfa-2b use different ways to stimulate the immune system and stop cancer cells from growing. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if PEG-interferon alfa-2b is more effective with or without thalidomide in treating recurrent high-grade gliomas.

PURPOSE: Randomized phase II trial to study the effectiveness of PEG-interferon alfa-2b with or without thalidomide in treating patients who have recurrent high-grade gliomas.

Condition	Treatment or Intervention	Phase
adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult brain stem glioma adult brain tumor adult glioblastoma Mixed Gliomas	Drug: PEG-interferon alfa-2b  Drug: thalidomide  Procedure: adjuvant therapy  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Procedure: biological response modifier therapy  Procedure: growth factor antagonist therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the antitumor efficacy, in terms of progression-free survival, of PEG-interferon alfa-2b with or without thalidomide in patients with recurrent high grade gliomas.
• Determine the toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to type of glioma (glioblastoma multiforme vs anaplastic glioma). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive PEG-interferon alfa-2b subcutaneously once weekly.
• Arm II: Patients receive PEG-interferon alfa-2b as in arm I and oral thalidomide once daily on day 1 and 3-42. Courses in both arms repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 96 patients (48 per treatment arm) will be accrued for this study within 12-16 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed supratentorial malignant primary gliomas including the following:
• Glioblastoma multiforme
• Anaplastic astrocytoma
• Anaplastic oligodendroglioma
• Anaplastic mixed oligoastrocytoma
• Malignant astrocytoma not otherwise specified
• Recurrent disease
• Failed prior radiotherapy
• Prior therapy for no more than 2 relapses
• Measurable or evaluable disease with evidence of tumor recurrence or progression by MRI or CT scan
• Scan performed within 14 days prior to study and on a stable steroid dose for at least 5-7 days
• Patients who have undergone prior resection of recurrent or progressive tumor require evaluable disease only
• Progressive disease must be confirmed (vs radiation necrosis) by positron emission tomography, thallium scan, MR spectroscopy, or surgery if received prior interstitial brachytherapy or stereotactic radiosurgery

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

Hepatic

• SGOT less than 2 times upper limit of normal (ULN)
• Bilirubin less than 2 times ULN

Renal

• Creatinine less than 1.5 mg/dL OR
• Creatinine clearance at least 60 mL/min

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception for 1 month prior, during, and for 4 months after treatment with thalidomide
• No disease that would obscure toxicity or dangerously alter drug metabolism
• No peripheral neuropathy greater than grade 1
• No other cancer within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No serious active infection
• No other serious concurrent medical illness
• No concurrent significant illness that would preclude study participation

PRIOR CONCURRENT THERAPY: Biologic therapy

• No prior PEG-interferon alfa-2B
• No concurrent immunotherapy

Chemotherapy

• At least 4 weeks since prior cytotoxic therapy
• At least 2 weeks since prior vincristine
• At least 6 weeks since prior nitrosoureas
• At least 3 weeks since prior procarbazine
• Prior radiosensitizer allowed
• No concurrent chemotherapy

Endocrine therapy

• At least 1 week since prior tamoxifen

Radiotherapy

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy
• No concurrent radiotherapy

Surgery

• See Disease Characteristics
• Recovered from prior surgery

Other

• Recovered from prior therapy
• At least 1 week since prior non-cytotoxic agent except radiosensitizer
• At least 1 week since prior isotretinoin
• No other concurrent investigational agents

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095,  United States; Recruiting
      UCSF Comprehensive Cancer Center, San Francisco,  California,  94143,  United States; Recruiting
Maryland
      Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda,  Maryland,  20892-1182,  United States; Recruiting
Massachusetts
      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States; Recruiting
Michigan
      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0316,  United States; Recruiting
New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
Pennsylvania
      Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15232,  United States; Recruiting
Texas
      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77030-4009,  United States; Recruiting
      Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas,  Texas,  75390-9154,  United States; Recruiting
      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78284-6220,  United States; Recruiting
Wisconsin
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792,  United States; Recruiting

Study chairs or principal investigators

Howard A. Fine, MD,  Study Chair,  NCI - Neuro-Oncology Branch   

Study ID Numbers:  CDR0000258609; NCI-03-C-0002; NABTC-0201; NCT00052650
Record last reviewed:  March 2004
Last Updated:  April 4, 2005
Record first received:  January 24, 2003
ClinicalTrials.gov Identifier:  NCT00052650
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08