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

This study has been completed.

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00019006
  Purpose

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.


Condition Intervention Phase
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
Phase I

MedlinePlus related topics:   Cancer    Lung Cancer    Pancreatic Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase I Pilot Study of Vaccine Therapy With Tumor-Specific Mutated Ras Peptides in the Adjuvant Setting in Patients With Colorectal, Pancreatic, or Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   March 1995

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older

Criteria
  1. Histopathologically confirmed diagnosis of Langerhans cell histiocytosis according to the criteria defined by the Histiocyte Society

    • 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:

    1. Multi-system at risk disease, defined as involvement of one or more risk organs (i.e., hematopoietic system, liver, spleen, or lungs)

      • 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

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Histologically documented solid tumor potentially expressing mutant ras Stage II/III adenocarcinoma of the lung following surgery or radiotherapy Limited or extensive small cell lung cancer in complete remission Dukes' C colorectal cancer following appropriate adjuvant chemotherapy Fully resected recurrent colorectal carcinoma Fully resected pancreatic carcinoma Tumor tissue available for determination of ras mutation Paraffin block or fresh tissue Specific point mutation in codon 12 required, which includes: Glycine to cysteine Glycine to aspartic acid Glycine to valine Tumor tissue available for preparation of a tumor cell line and tumor or lymph node tissue for expansion of tumor infiltrating lymphocytes for in vitro laboratory studies preferred No history of CNS metastases --Prior/Concurrent Therapy-- Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: At least 4 weeks since prior steroids and recovered Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics Not specified --Patient Characteristics-- Age: Over 18 Performance status: ECOG 0-1 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Lymphocyte count at least 600/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL ALT and AST no greater than 4 times normal Hepatitis B and C surface antigen negative Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No active ischemic heart disease (New York Heart Association class III/IV) No myocardial infarction within 6 months No history of arrhythmia No clinical symptoms suggesting cardiac insufficiency Pulmonary: No clinical symptoms suggesting pulmonary insufficiency Immunologic: Responsive to anergy skin testing with mumps, trichophyton, or candida antigens HIV negative No autoimmune disease, e.g.: Systemic lupus erythematosus Multiple sclerosis Ankylosing spondylitis Other: No active infection requiring antibiotics No history of malignancy except curatively treated basal cell skin carcinoma or curatively treated carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00019006

Locations
United States, Maryland
Medicine Branch    
      Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

Investigators
Study Chair:     Samir N. Khleif     National Cancer Institute (NCI)    
  More Information


Study ID Numbers:   CDR0000063475, NCI-94-C-0096D, NCI-T93-0152N
First Received:   March 1, 2007
Last Updated:   March 1, 2007
ClinicalTrials.gov Identifier:   NCT00019006
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult solid tumor  
body system/site cancer  
cancer  
colon cancer  
colorectal cancer  
extensive stage small cell lung cancer  
gastrointestinal cancer  
genetic condition  
limited stage small cell lung cancer  
lung cancer  
non-small cell lung cancer  
pancreatic cancer  
rectal cancer  
recurrent colon cancer  
recurrent pancreatic cancer  
recurrent rectal cancer
small cell lung cancer
solid tumor
stage I pancreatic cancer
stage II non-small cell lung cancer
stage II pancreatic cancer
stage III colon cancer
stage III non-small cell lung cancer
stage III pancreatic cancer
stage III rectal cancer
stage IV pancreatic cancer
stage IVA pancreatic cancer
stage IVB pancreatic cancer
stage, colon cancer
stage, non-small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Rectal Neoplasms
Gastrointestinal Diseases
Pancreatic Neoplasms
Colonic Diseases
Rectal Diseases
Respiratory Tract Diseases
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Rectal cancer
Endocrine Gland Neoplasms
Non-small cell lung cancer
Digestive System Neoplasms
Endocrine System Diseases
Intestinal Diseases
Intestinal Neoplasms
Recurrence
Rectal neoplasm
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Digestive System Diseases
Lung Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Disease Attributes
Neoplasms
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on October 31, 2008




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