Vaccine Therapy In Treating Patients With Colon, Pancreatic, Or Lung Cancer

Study Overview

Vaccine Therapy in Treating Patients With Colon, Pancreatic, or Lung Cancer

RATIONALE: Vaccines made from mutated ras peptides may make the body build an immune response to and kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of a vaccine containing mutated ras peptides and an immune adjuvant in treating patients who have colon, pancreatic, or lung cancer.

OBJECTIVES: I. Determine whether endogenous cellular or humoral immunity to a tumor-specific mutated ras protein is present in patients with colorectal, pancreatic, or lung cancer. II. Determine whether vaccination with a synthetic peptide corresponding to the tumor's ras mutation combined with Detox-B adjuvant can induce or boost cellular immunity to that particular mutation in this patient population. III. Determine the type and characteristics of any cellular immunity generated in these patients treated with this regimen. IV. Determine the tolerance and toxicity spectra of such peptides given with Detox-B adjuvant in these patients. V. Determine the immune response associated with each peptide dose in these patients. VI. Assess any tumor response that may occur with treatment in these patients treated with this regimen. PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive tumor-specific mutated ras peptide combined with Detox-B adjuvant subcutaneously monthly for 3 months. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease or with a specific immunologic response may receive 3 additional monthly vaccinations. Cohorts of 3-6 patients receive escalating doses of tumor-specific mutated ras peptide combined with Detox-B adjuvant until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 33 patients (12 in the adjuvant setting) will be accrued for this study within 12 months.

Recurrent Colon Cancer
Extensive Stage Small Cell Lung Cancer
Stage III Pancreatic Cancer
Stage III Rectal Cancer
Limited Stage Small Cell Lung Cancer
Recurrent Pancreatic Cancer
Recurrent Rectal Cancer
Stage III Non-small Cell Lung Cancer
Stage I Pancreatic Cancer
Stage II Non-small Cell Lung Cancer
Stage IVB Pancreatic Cancer
Stage II Pancreatic Cancer
Stage III Colon Cancer
Stage IVA Pancreatic Cancer

DRUG: Detox-B adjuvant
DRUG: ras peptide cancer vaccine

CDR0000063475
NCI-94-C-0096D
NCI-T93-0152N

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-03-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-03-01
First Submitted that Met QC Criteria 2007-03-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-03-04
First Posted (ACTUAL) 2007-03-02	Results First Posted N/A	Last Verified 2024-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Demonstration of CD1a antigenic determinants on the surface of lesional cells (by immunocytology or immunohistology) or Birbeck granules in lesional cells by electron microscopy 2. Considered at risk or low risk according to the following criteria:

No single-system lung involvement 2. Multi-system low-risk disease

Multiple organs involved but without involvement of risk organs 3. Single-system disease

Multifocal bone disease (i.e., lesions in 2 or more different bones)
Localized special site involvement, such as CNS-risk lesions with intracranial soft tissue extension or vertebral lesions with intraspinal soft tissue extension

Vault lesions are not regarded as CNS-risk lesions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Samir N. Khleif, National Cancer Institute (NCI)

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record