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

Alternate Title

Gene Therapy in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	Pharmaceutical / Industry	BIOGEN-C-1502 UARIZ-HSC-01197, NCI-V02-1696, NCT00036725

Objectives

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

Entry 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

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Biogen Idec, Incorporated

Steven Rosenfeld, MD, PhD, Protocol chair		Ph: 205-934-1432 Email: s_rosenfeld@mail.neruo.uab.edu

Registry Information
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
Trial Start Date		2002-01-01
Registered in ClinicalTrials.gov		NCT00036725
Date Submitted to PDQ		2002-02-27
Information Last Verified		2006-09-25

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