Gene Therapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer

NCT00004225 | Completed Phase 1

• 2 other identifiers: CDR0000067466ECOG-8597
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Inserting the gene for p53 into a person's cancer cells may improve the body's ability to fight cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase I trial to study the effectiveness of gene therapy plus radiation therapy in treating patients who have non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer

Interventions

Ad5CMV-p53 gene BIOLOGICAL

radiation therapy RADIATION

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically proven non-small cell lung cancer with at least 1 lesion accessible for endobronchial or percutaneous injection * Measurable or evaluable disease * Must have a requirement for palliative radiotherapy to the thorax * Clinically stable enough to undergo 3 adenovirus injections PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0 or 1 Life expectancy: * At least 12 weeks Hematopoietic: * Platelet count greater than 100,000/mm\^3 Hepatic: * PT and PTT normal Renal: * Not specified Cardiovascular: * No New York Heart Association class III or IV heart disease Other: * No active systemic viral, bacterial, or fungal infection requiring treatment * No concurrent illness requiring hospitalization or IV medications or psychologic, familial, sociologic, geographic, or other concurrent condition that would preclude adequate follow up and compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior adenoviral gene therapy * Any number of any type of other prior biologic therapy allowed Chemotherapy: * Any number of any type of prior chemotherapy allowed * At least 2 weeks since prior systemic cancer therapy and no worse than grade 2 toxicity in any organ Endocrine therapy: * Any number of any type of prior endocrine therapy allowed Radiotherapy: * See Disease Characteristics * No prior radiotherapy greater than 50 Gy if prior and concurrent radiation fields include the spinal cord * No prior radiotherapy in fraction sizes greater than 2 Gy with the spinal cord in the concurrent radiation field Surgery: * At least 4 weeks since surgical resection of lung tissue * At least 2 weeks since any other prior surgery requiring general anesthesia and recovered

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

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

advexin; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Joan H. Schiller, MD

  University of Wisconsin, Madison

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 28, 2000
• First Posted: January 27, 2003
• Study Start: January 1, 2000
• Last Updated: July 7, 2010

Record last verified: 2004-04

Locations

US (1)