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PEG-Interferon Alfa-2b and Thalidomide in Treating Patients With Recurrent High-Grade Gliomas
This study is ongoing, but not recruiting participants.
Study NCT00052650   Information provided by National Cancer Institute (NCI)
First Received: January 24, 2003   Last Updated: April 9, 2009   History of Changes

January 24, 2003
April 9, 2009
March 2004
December 2010   (final data collection date for primary outcome measure)
Progression-free survival at 6 months [ Designated as safety issue: No ]
Progression-free survival at 6 months
Complete list of historical versions of study NCT00052650 on ClinicalTrials.gov Archive Site
Response (complete and partial response) [ Designated as safety issue: No ]
Response (complete and partial response)
 
PEG-Interferon Alfa-2b and Thalidomide in Treating Patients With Recurrent High-Grade Gliomas
A Phase II Study Of Peginterferon Alpha-2B (PEG-INTRON) And Thalidomide In Adults With Recurrent High Grade Gliomas

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: This phase II trial to study the effectiveness of PEG-interferon alfa-2b and thalidomide in treating patients who have recurrent high-grade gliomas.

OBJECTIVES:

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

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.

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

Phase II
Interventional
Treatment, Active Control
Brain and Central Nervous System Tumors
  • Biological: PEG-interferon alfa-2b
  • Drug: thalidomide
  • Procedure: adjuvant therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
64
 
December 2010   (final data collection date for primary outcome measure)

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

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00052650
Howard A. Fine, NCI - Neuro-Oncology Branch
CDR0000258609, NCI-03-C-0002, NABTC-0201
National Cancer Institute (NCI)
 
Study Chair: Howard A. Fine, MD NCI - Neuro-Oncology Branch
National Cancer Institute (NCI)
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP