Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

PEG-Interferon alfa-2b and Thalidomide in Treating Patients With Recurrent High-Grade Gliomas

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	NCI-03-C-0002 NABTC-0201, NCT00052650

Objectives

1. Determine the antitumor efficacy, in terms of progression-free survival, of PEG-interferon alfa-2b and thalidomide in patients with recurrent high grade gliomas.
2. Determine the toxic effects of these regimens in these patients.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

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

Chemotherapy

• No prior thalidomide
• 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
• At least 2 weeks since prior investigational agents

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• More than 8 weeks

Hematopoietic

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

A total of 64 patients will be accrued for this study.

Outcomes

Progression-free survival at 6 months

Response (complete and partial response)

Outline

This is a multicenter study. Patients are stratified according to type of glioma (glioblastoma multiforme vs anaplastic glioma).

Patients receive PEG-interferon alfa-2b subcutaneously once weekly and oral thalidomide once daily for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Howard Fine, MD, Protocol chair		Ph: 301-402-6298

Related Information

Web site for additional information

Registry Information
Official Title		A Phase II Study Of Peginterferon Alpha-2B (PEG-INTRON) And Thalidomide In Adults With Recurrent High Grade Gliomas
Trial Start Date		2004-03-31
Trial Completion Date		2010-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00052650
Date Submitted to PDQ		2002-10-21
Information Last Verified		2008-10-24

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