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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ras peptide cancer vaccine
sargramostim
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 2, 2000
Last Updated
June 18, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005630
Brief Title
Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer
Official Title
Vaccination of Non-Small Cell Lung Cancer Patients Against Mutated K-Ras: A Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
May 2002 (Actual)
Study Completion Date
May 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Determine whether a specific T-cell response can be induced in patients with stage IB-IV non-small cell lung cancer treated with mutant K-ras peptide vaccine (limited to the specific K-ras peptide mutation in their tumors) and sargramostim (GM-CSF). Determine whether skin test reactivity or HLA type correlates with the induction of anti-K-ras immune responses in patients treated with this regimen. Determine the toxicity of this regimen in these patients. OUTLINE: Patients receive sargramostim (GM-CSF) intradermally (ID) on days 1-10 beginning a maximum of 6 months after complete surgical resection. Patients receive mutant K-ras peptide vaccine (limited to the specific K-ras mutation in their tumors) ID on day 7. Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 and 12 weeks. PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
ras peptide cancer vaccine
Intervention Type
Biological
Intervention Name(s)
sargramostim

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee M. Krug, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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

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