A PHASE I TRIAL OF HSV-TK ADENOVIRUS GENE THERAPY FOR PRIMARY BRAIN TUMORS

Abramson Cancer Center at Penn Medicine2 sites in 1 countryStarted: February 1996Last updated: March 13, 2019

Conditions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor: Abramson Cancer Center at Penn Medicine
Locations: 2

Study Overview Study Design Eligibility Criteria Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

RATIONALE: Inserting the gene for herpes virus into a person's cells may improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy using antiviral drugs such as ganciclovir.

PURPOSE: Phase I trial to study the effectivenesss of gene therapy in treating patients with primary brain tumors.

Detailed Description

OBJECTIVES: I. Assess the response to a stereotactically administered recombinant adenovirus vector carrying the herpes simplex virus thymidine kinase gene (H5.010RSVTK) followed by intravenous ganciclovir in patients with recurrent malignant glioma. II. Estimate the maximum tolerated dose of H5.010RSVTK in these patients. III. Describe the toxic effects of H5.010RSVTK. IV. Assess the efficiency of gene transfer and duration of transgene expression in these patients. V. Assess quantitative and qualitative glucose metabolic activity of tumoral sites by positron emission tomography. VI. Analyze the immunologic response to adenovirus transduction in these patients. VII. Determine the benefit and toxicity of multiple doses of H5.010RSVTK in patients with resectable tumors.

OUTLINE: This is a dose-finding study. All patients receive stereotactically injected H5.010RSVTK (a recombinant adenovirus vector containing the herpes simplex virus thymidine kinase gene). Cohorts of 3-6 patients receive escalating doses of H5.010RSVTK until the maximum tolerated dose is reached. Ganciclovir is then given on the third post-injection day. Patients with unresectable tumors receive ganciclovir for 14 consecutive days. Patients with resectable tumors receive ganciclovir for 7 consecutive days before undergoing craniotomy with optimal debulking and injection of a second dose of the adenovirus vector followed by ganciclovir for 14 more days. Patients are followed monthly for survival.

PROJECTED ACCRUAL: A total of 18 patients (9 with resectable tumors and 9 with unresectable tumors) will be entered over 3 years.

Study Design

Study Type: Interventional
Primary Purpose: Treatment

Eligibility Criteria

Ages: 18 Years to 120 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Investigators

Sponsor

Abramson Cancer Center at Penn Medicine

Sponsor Class

Other

Study Sites (2)

Loading locations...

Similar Trials

Completed

Phase 1

Gene Therapy and Ganciclovir in Treating Patients With Stage IV MelanomaMelanoma (Skin)

NCT00005057National Human Genome Research Institute (NHGRI)

Terminated

Phase 1

Phase I Pilot Study of Liver-Directed Gene Therapy for Partial Ornithine Transcarbamylase DeficiencyOrnithine Transcarbamylase Deficiency Disease

NCT00004386Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Terminated

Phase 1

Safety of a New Type of Treatment Called Gene Transfer for the Treatment of Severe Hemophilia BHemophilia B

NCT00076557Avigen15

Completed

Phase 1

Gene Therapy in Treating Patients With Recurrent Malignant GliomasBrain and Central Nervous System Tumors

NCT00004041Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Terminated

Phase 1

Biological Therapy in Treating Women With Breast Cancer That Has Spread to the LiverMetastatic CancerBreast Cancer

NCT00301106Max Sung2