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Gene Therapy in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on May 13, 2002.   Last Updated on May 30, 2009   History of Changes
Sponsor: Biogen Idec
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00036725
  Purpose

RATIONALE: Inserting the gene for interferon-beta into a person's glioblastoma cells may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have recurrent or progressive glioblastoma multiforme.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Biological: recombinant adenovirus-hIFN-beta
Procedure: conventional surgery
Phase I

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Muliti-Center, Open Label, Two Part, Dose Escalation Study To Determine The Tolerability Of Interferon-Beta Gene Transfer (BG00001) In The Treatment Of Recurrent Or Progressive Glioblastoma Multiforme

Resource links provided by NLM:


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

Study Start Date: January 2002
Detailed Description:

OBJECTIVES:

  • Determine the major toxic effects of intratumor BG00001 (adenoviral vector encoding human interferon beta) in patients with recurrent or progressive glioblastoma multiforme.
  • Determine the maximum tolerated dose of this drug in these patients.
  • Determine the 6-month progression-free survival and 12-month overall survival of patients treated with this drug.
  • Determine the immune response in patients treated with this drug.
  • Determine the anti-tumor activity of this drug in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive intratumor BG00001 by stereotactic injection on day 1. Patients undergo tumor resection and receive the second injection of BG00001 into the tumor bed and remaining tumor on day 8 in the absence of unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BG00001 until the maximum tolerated dose (MTD) is determined. The MTD is defined as one dose level below that at which either 2 of 3 or 2 or more of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 14-17 additional patients receive treatment as above with the MTD of BG00001.

Patients are followed on days 9, 10, 11, 12, 15, 22, and 29; weeks 8, 17, 26, and 52; and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 3-50 patients will be accrued for this study within 1 year.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed glioblastoma multiforme

    • Recurrent or progressive disease after prior treatment as evidenced by gadolinium-enhanced MRI
  • Recurrent or progressive tumor must be confirmed as malignant by biopsy
  • Resection must be clinically indicated

    • Tumor must be amenable to radical resection
  • Must be on anticonvulsant therapy with therapeutic serum levels for at least 2 weeks prior to study
  • No brainstem or optic chiasm involvement of tumor
  • No more than 1 cm linear dimension of contact between gadolinium-enhancing tumor and a cerebral ventricle

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • ALT and AST no greater than 4 times upper limit of normal (ULN)
  • PT no greater than 2 seconds above ULN
  • Bilirubin no greater than 1.5 mg/dL

Renal:

  • Creatinine no greater than 2 times ULN
  • Sodium 125-150 mEq/L
  • Potassium 3.5-5.5 mEq/L

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior intolerance to corticosteroids
  • No medical condition that would preclude the use of corticosteroids
  • No uncontrolled seizure disorder
  • No other clinically significant, uncontrolled medical illness
  • No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, superficial transitional cell carcinoma of the bladder, or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior BG00001
  • No prior treatment with a gene delivery vector or therapeutic adenovirus

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • No concurrent chemotherapy

Endocrine therapy:

  • Must receive corticosteroids beginning at least 1 week before baseline MRI and ending after the second dose of study drug

Radiotherapy:

  • At least 8 weeks since prior radiotherapy, including interstitial radiation or radiosurgery
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • See Disease Characteristics
  • At least 4 weeks since prior investigational drugs or therapy
  • No other investigational or approved anticancer therapy during and for 8 weeks after study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036725

Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Pennsylvania
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104-4283
Sponsors and Collaborators
Biogen Idec
Investigators
Study Chair: Steven S. Rosenfeld, MD, PhD University of Alabama at Birmingham
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00036725     History of Changes
Other Study ID Numbers: CDR0000069312, BIOGEN-C-1502, UARIZ-HSC-01197, NCI-V02-1696
Study First Received: May 13, 2002
Last Updated: May 30, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor
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

ClinicalTrials.gov processed this record on February 09, 2012