Gene Therapy in Treating Patients With Primary Brain Tumors

NCT00002824 | Completed Phase 1

• 3 other identifiers: CDR0000065004UPCC-3394NCI-H96-0976
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumor; adult glioblastoma; adult anaplastic astrocytoma; adult giant cell glioblastoma; adult gliosarcoma

Interventions

gene therapy BIOLOGICAL

chemotherapy DRUG

ganciclovir DRUG

conventional surgery PROCEDURE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically confirmed malignant glioma, including: Anaplastic astrocytoma Glioblastoma Evidence of recurrence by MRI and positron emission tomography despite primary treatment that included radiotherapy with or without chemotherapy Stereotactically accessible tumor Solitary tumor preferred Largest tumor surgically accessible for debulking if multifocal disease Not adjacent to optic chiasm or brain stem No subependymal spread No herniation or marked midline shift Consent for autopsy required PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70%-100% Hematopoietic: Hematologic parameters normal Hepatic: Hepatic parameters normal (less than twice normal if on anticonvulsants) Renal: Renal parameters normal Cardiovascular: No congestive heart failure No angina Other: No medical contraindication to neurosurgery and fluid injection into brain No serious uncontrolled infection Negative pregnancy test required of fertile women prior to entry Adequate contraception required of fertile women during and for 3 months after treatment PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 2 months since radiotherapy Surgery: Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms; Glioblastoma; Astrocytoma; Gliosarcoma

Interventions

Genetic Therapy; Drug Therapy; Ganciclovir

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Genetic Engineering; Genetic Techniques; Investigative Techniques; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jane B. Alavi, MD

  Abramson Cancer Center at Penn Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: July 29, 2004
• Study Start: February 1, 1996
• Last Updated: March 13, 2019

Record last verified: 2000-07

Locations

US (1)