NCT00019006

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1995

Completed
12 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2007

Completed
Last Updated

March 4, 2024

Status Verified

March 1, 2024

First QC Date

March 1, 2007

Last Update Submit

March 1, 2024

Conditions

Recurrent Colon CancerExtensive Stage Small Cell Lung CancerStage III Pancreatic CancerStage III Rectal CancerLimited Stage Small Cell Lung CancerRecurrent Pancreatic CancerRecurrent Rectal CancerStage III Non-small Cell Lung CancerStage I Pancreatic CancerStage II Non-small Cell Lung CancerStage IVB Pancreatic CancerStage II Pancreatic CancerStage III Colon CancerStage IVA Pancreatic Cancer

Keywords

adult solid tumorbody system/site cancercancercolon cancercolorectal cancerextensive stage small cell lung cancergastrointestinal cancergenetic conditionlimited stage small cell lung cancerlung cancernon-small cell lung cancerpancreatic cancerrectal cancerrecurrent colon cancerrecurrent pancreatic cancerrecurrent rectal cancersmall cell lung cancersolid tumorstage I pancreatic cancerstage II non-small cell lung cancerstage II pancreatic cancerstage III colon cancerstage III non-small cell lung cancerstage III pancreatic cancerstage III rectal cancerstage IV pancreatic cancerstage IVA pancreatic cancerstage IVB pancreatic cancerstage, colon cancerstage, non-small cell lung cancerstage, pancreatic cancerstage, rectal cancerstage, small cell lung cancerthorax/respiratory cancer

Interventions

Detox-B adjuvantDRUG
ras peptide cancer vaccineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
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

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

Sponsors & Collaborators

Study Sites (1)

Medicine Branch

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Colonic NeoplasmsPancreatic NeoplasmsRectal NeoplasmsCarcinoma, Non-Small-Cell LungNeoplasmsColorectal NeoplasmsGastrointestinal NeoplasmsGenetic Diseases, InbornLung NeoplasmsSmall Cell Lung Carcinoma

Interventions

detox adjuvant

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesRectal DiseasesCarcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Samir N. Khleif

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

March 1, 2007

First Posted

March 2, 2007

Study Start

March 1, 1995

Last Updated

March 4, 2024

Record last verified: 2024-03

Locations

US(1)