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

Alternate Title

Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary Brain Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 18 and over NCI DUMC-1529-01-8R4 DUMC-1363-97-9, DUMC-1409-98-9R1, DUMC-1529-00-8R3, DUMC-1630-99-9R2, DUMC-97112, NCI-5950NS20023, NCI-G98-1471, NCT00003478

Objectives

1. Determine which one of two delivery techniques (bolus injection versus microinfusion) provides the greater distribution volume of iodine I 131 antitenascin monoclonal antibody 81C6 (I 131 MAb 81C6) administered intratumorally in patients with newly diagnosed or recurrent malignant primary brain tumors.
2. Determine the maximum tolerated dose of I 131 MAb 81C6 delivered intratumorally in these patients.
3. Evaluate the efficacy of I 131 MAB 81C6 delivered intratumorally in these patients.

Entry Criteria

Disease Characteristics:

• Histologically proven newly diagnosed or recurrent primary intracranial WHO grade III or IV glioma



• Reactivity of tumor cells with 81C6 demonstrated by immunohistology with either a polyclonal rabbit antibody or the monoclonal mouse antibody



• Radiographic evidence of a single lesion by MRI or CT scan
  • No greater than 2 to 5 cm



• No cerebral herniation syndrome



• Midline brain shift less than 0.5 cm

Prior/Concurrent Therapy:

Biologic therapy:

• No concurrent autologous bone marrow transplant

Chemotherapy:

• No more than 1 prior conventional or phase II chemotherapy regimen
• No prior phase I chemotherapy regimens
• At least 4 weeks since prior chemotherapy
• No concurrent systemic chemotherapy

Endocrine therapy:

• Corticosteroids allowed but must be on stable dose for at least 1 week

Radiotherapy:

• At least 3 months since radiotherapy to site of measurable disease in the nervous system, unless evidence of progression

Surgery:

• Not specified

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count greater than 1000/mm³
• Platelet count greater than 100,000/mm³
• Hemoglobin greater than 10 g/dL

Hepatic:

• Bilirubin less than 1.5 mg/dL
• Alkaline phosphatase less than 1.5 times normal
• SGOT less than 1.5 times normal

Renal:

• Creatinine less than 2.0 mg/dL

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No allergies to iodine or local anesthetics

Expected Enrollment

At least 10 patients will be accrued for this study within 1 year.

Outline

This is a randomized, dose-escalation study.

Patients are randomized to receive iodine I 131 antitenascin monoclonal antibody 81C6 (I 131 MAb 81C6) by one of two delivery techniques first, then crossover to receive the antibody by the other technique 3 days later. Each patient then receives a therapeutic dose by the most efficient method. Both methods are delivered via a stereotactically-placed intralesional catheter.

• Arm I: Bolus injection method



• Arm II: Microinfusion delivery method

Cohorts of 3-6 patients receive escalating doses of I 131 MAb 81C6, with dose escalation occurring separately for each arm. After 10 patients are enrolled and the best method of administration is determined, all subsequent patients receive I 131 MAb 81C6 by that method, and the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more the 2 of 6 patients experience dose-limiting toxicity.

Patients with newly diagnosed tumors for which no effective conventional therapy exists, such as malignant glial tumors, are treated with external beam radiotherapy within 4 months after I 131 MAb 81C6 infusion. Patients with recurrent tumors receive no other therapy unless tumor progresses.

Patients are followed at 4, 8, 16, and 24 weeks and then every 12 weeks for one year.

Trial Contact Information

Trial Lead Organizations

Duke Comprehensive Cancer Center

Darell Bigner, MD, PhD, Protocol chair(Contact information may not be current)		Ph: 919-684-5018 Email: bigne001@mc.duke.edu

Registry Information
Official Title		Phase I Study of Intra-Tumoral, Radiolabeled, Anti-Tenascin Monoclonal Antibody 81C6 in the Treatment of Patients With Malignant Primary Brain Tumors
Trial Start Date		1997-10-31
Registered in ClinicalTrials.gov		NCT00003478
Date Submitted to PDQ		1998-08-04
Information Last Verified		2005-01-31
NCI Grant/Contract Number		P30-CA14236

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