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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.
First Received: January 24, 2003   Last Updated: April 9, 2009   History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00052650
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Biological: PEG-interferon alfa-2b
Drug: thalidomide
Procedure: adjuvant therapy
Phase II

Study Type: Interventional
Study Design: Treatment, Active Control
Official Title: A Phase II Study Of Peginterferon Alpha-2B (PEG-INTRON) And Thalidomide In Adults With Recurrent High Grade Gliomas

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival at 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response (complete and partial response) [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: March 2004
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052650

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Study Chair: Howard A. Fine, MD NCI - Neuro-Oncology Branch
  More Information

Additional Information:
No publications provided

Responsible Party: NCI - Neuro-Oncology Branch ( Howard A. Fine )
Study ID Numbers: CDR0000258609, NCI-03-C-0002, NABTC-0201
Study First Received: January 24, 2003
Last Updated: April 9, 2009
ClinicalTrials.gov Identifier: NCT00052650     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult brain stem glioma
adult mixed glioma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Anti-Infective Agents
Thalidomide
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Central Nervous System Neoplasms
Anti-Bacterial Agents
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Glioma
Nervous System Neoplasms
Interferon-alpha
Neoplasms by Histologic Type
Growth Substances
Nervous System Diseases
Interferons
Immunosuppressive Agents
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neuroectodermal Tumors
Neoplasms
Peginterferon alfa-2b
Neoplasms, Neuroepithelial
Interferon Alfa-2a
Interferon Alfa-2b

ClinicalTrials.gov processed this record on November 27, 2009