Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00052715
First received: January 24, 2003
Last updated: February 6, 2009
Last verified: March 2005
  Purpose

RATIONALE: Biological therapies such as poly-ICLC use different ways to stimulate the immune system and stop tumor cells from growing. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining biological therapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining poly-ICLC with radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: poly ICLC
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial Of Poly-ICLC For Glioblastoma

Resource links provided by NLM:


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

Study Start Date: November 2002
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the efficacy of poly ICLC and radiotherapy, in terms of total survival from date of diagnosis, in patients with newly diagnosed glioblastoma multiforme.
  • Determine the safety and toxicity profile of this regimen in these patients.
  • Determine the 12-month survival rate in patients treated with this regimen.
  • Assess progression-free survival at 6 months and median progression-free survival from date of diagnosis of patients treated with this regimen.
  • Assess response in patients treated with this regimen.
  • Assess changes in neurological status in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Within 1-4 weeks after surgery, patients receive poly ICLC intramuscularly 3 times weekly (on days 1, 3, and 5). Treatment continues in the absence of disease progression or unacceptable toxicity.

One week after the initiation of poly ICLC, patients undergo external beam radiotherapy once daily 5 days a week for 6 weeks.

Patients are followed monthly for 1 year and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed intracranial glioblastoma multiforme (GBM) or gliosarcoma by biopsy or resection within the past 28 days

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

  • No significant medical illness that cannot be controlled adequately with appropriate therapy or that would compromise tolerability of study therapy
  • No other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off all therapy for that disease for at least 3 years
  • No active infection
  • No disease that would obscure toxicity or dangerously alter drug metabolism
  • No other serious concurrent medical illness
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior polifeprosan 20 with carmustine implant (Gliadel wafer)
  • No concurrent chemotherapy

Endocrine therapy

  • Concurrent corticosteroids to treat symptoms or prevent complications are allowed

Radiotherapy

  • No prior radiotherapy to the brain
  • No concurrent stereotactic radiosurgery
  • No concurrent brachytherapy

Surgery

  • See Disease Characteristics

Other

  • No prior cytotoxic or noncytotoxic drug therapy for GBM
  • No prior experimental drug therapy for GBM
  • No other concurrent cytotoxic or noncytotoxic drug therapy for GBM
  • Concurrent analgesics, antiepileptics, or other drugs to treat symptoms or prevent complications are allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052715

Locations
United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
North American Brain Tumor Consortium
Investigators
Principal Investigator: Michael Prados, MD University of California, San Francisco
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00052715     History of Changes
Other Study ID Numbers: CDR0000258685, NABTC-0105
Study First Received: January 24, 2003
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Glioblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Poly ICLC
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014