Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer

NCT00005630 | Completed Phase 1

• 3 other identifiers: 99-028CDR0000067783NCI-G00-1775
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy and sargramostim in treating patients who have non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancer; stage II non-small cell lung cancer; large cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer

Interventions

ras peptide cancer vaccine BIOLOGICAL

sargramostim BIOLOGICAL

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically proven stage IB-IV non-small cell lung cancer * Non-squamous cell histology only * Must have undergone curative surgery within the past 6 months and must be free of recurrence * Tumor must demonstrate a specific K-ras mutation at codon 12 for which a vaccine preparation is available PATIENT CHARACTERISTICS: Age: * Over 17 Performance status: * Karnofsky 70-100% Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No New York Heart Association class III or IV heart disease Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No concurrent medical condition that would preclude compliance or immunologic response to study treatment * No other serious concurrent medical condition * No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the uterine cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 3 weeks since prior postoperative chemotherapy and recovered Endocrine therapy: * No concurrent systemic steroids * Concurrent inhaled steroids allowed Radiotherapy: * No prior radiotherapy to spleen * At least 3 weeks since prior postoperative radiotherapy and recovered Surgery: * See Disease Characteristics * No prior splenectomy Other: * No concurrent immunosuppressive drugs or antiinflammatory drugs

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

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

Interventions

sargramostim

Condition Hierarchy (Ancestors)

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

Study Officials

• Lee M. Krug, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: May 2, 2000
• First Posted: October 1, 2003
• Study Start: July 1, 1999
• Primary Completion: May 1, 2002
• Study Completion: May 1, 2002
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

US (1)