NCT00004080

Gene Therapy in Treating Patients With Recurrent or Progressive Brain Tumors

Assessment of the Safety and Transduction Efficiency of SCH58500, An Adenoviral Vector p53 Delivery System, to Patients With Recurrent Malignant Brain Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Inserting the gene for p53 into a person's brain cells may improve the body's ability to fight cancer. PURPOSE: Phase I trial to study the effectiveness of p53 gene therapy with SCH-58500 in treating patients who have recurrent, or progressive glioblastoma multiforme, anaplastic astrocytoma, or anaplastic mixed glioma that can be removed during surgery.

Detailed description

OBJECTIVES: I. Estimate the efficiency of tumor cell transduction with adenovirus p53 delivered stereotactically to patients with recurrent or progressive resectable glioblastoma multiforme, anaplastic astrocytoma, or anaplastic mixed glioma. II. Determine the maximum tolerated dose of adenovirus p53 delivered stereotactically and with craniotomy in these patients. III. Correlate analysis of predelivery tumor specimen p53 gene status with postdelivery p53 gene status, clinical status, and tumor staging in these patients treated with this regimen. IV. Correlate analysis of postdelivery tumor specimen p53 gene status and local tumor immune response with postdelivery clinical status and tumor imaging in these patients treated with this regimen. OUTLINE: This is a dose escalation, multicenter study. Patients receive SCH-58500 via stereotactic injection into the tumor, followed 24-72 hours later by craniotomy. Patients undergo tumor resection, followed by injection of SCH-58500 into the tumor bed during craniotomy. Cohorts of 3-6 patients receive escalating doses of SCH-58500 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose immediately preceding that at which 3 of 3-6 patients experience dose limiting toxicity. Patients are followed at day 28, then every 2 months for 1 year, and then annually thereafter, until another therapy is begun or disease progression is documented. PROJECTED ACCRUAL: A total of 21-42 patients will be accrued for this study over 14-27 months.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
BIOLOGICAL	recombinant adenovirus-p53 SCH-58500
PROCEDURE	conventional surgery

Timeline

• Start date: 1999-12-01
• First posted: 2004-08-05
• Last updated: 2009-02-09