Gene Therapy in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Surgically Removed

NCT00003649 | Completed Phase 1

• 2 other identifiers: CDR0000066741E-6597
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE: Exposing tumor cells to the p53 gene may improve the body's ability to fight non-small cell lung cancer. PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have non-small cell lung cancer that cannot be surgically removed.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; bronchoalveolar cell lung cancer

Interventions

Ad5CMV-p53 gene BIOLOGICAL

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed unresectable non-small cell lung cancer with a growth pattern allowing access to the majority of tumor cells via the airway (e.g., bronchioloalveolar or papillary adenocarcinoma) PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * At least 12 weeks Hematopoietic: * Platelet count greater than 100,000/mm\^3 * Prothrombin time and partial thromboplastin time normal Hepatic: * Bilirubin less than 1.5 mg/dL Renal: * Creatinine less than 1.5 mg/dL Cardiovascular: * No New York Heart Association class III or IV heart disease Pulmonary: * Room air oxygen saturation greater than 90% * FEV1 greater than 1.0 L pCO2 less than 50 Other: * HIV negative * No active systemic viral, bacterial, or fungal infections requiring treatment * No concurrent illness requiring hospitalization or intravenous medication * Not pregnant or nursing * Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior adenovirus gene therapy * At least 2 weeks since any systemic biologic therapy including prior biologic response modifiers and recovered Chemotherapy: * At least 2 weeks since any prior systemic chemotherapy and recovered Endocrine therapy: * Recovered from any prior endocrine therapy Radiotherapy: * Recovered from any prior radiotherapy Surgery: * At least 2 weeks since any surgical procedure requiring anesthesia * At least 4 weeks since prior surgical resection of lung tissues Other: * No other concurrent therapy

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 (3)

Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus

Nashville, Tennessee, 37212, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

CCOP - Green Bay

Green Bay, Wisconsin, 54301, United States

Location

Related Publications (2)

• Keedy V, Wang W, Schiller J, Chada S, Slovis B, Coffee K, Worrell J, Thet LA, Johnson DH, Carbone DP. Phase I study of adenovirus p53 administered by bronchoalveolar lavage in patients with bronchioloalveolar cell lung carcinoma: ECOG 6597. J Clin Oncol. 2008 Sep 1;26(25):4166-71. doi: 10.1200/JCO.2007.15.6927.

  PMID: 18757331 RESULT

• Kubba SV, Adak S, Schiller J, et al.: Phase I trial of adenovirus p53 in bronchioalveolar cell lung carcinoma (BAC) administered by bronchioalveolar lavage. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A1904, 2000.

  RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

advexin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma of Lung; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• David P. Carbone, MD, PhD

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: April 30, 2003
• Study Start: November 17, 1998
• Study Completion: June 15, 2007
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

US (3)