Vaccine Therapy in Treating Patients With Stage IIB, Stage III, or Stage IV Colorectal Cancer

NCT00091286 | Terminated Early Phase 1

• 3 other identifiers: 9976UVACC-GI37UVACC-23302
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. PURPOSE: This clinical trial is studying how well vaccine therapy works in treating patients with stage IIB, stage III, or stage IV colorectal cancer.

Conditions

Colorectal Cancer

Keywords

recurrent colon cancer; stage IIB colon cancer; stage IIIA colon cancer; stage IIIB colon cancer; stage IIIC colon cancer; stage IVA colon cancer; stage IVB colon cancer; recurrent rectal cancer; stage IIB rectal cancer; stage IIIA rectal cancer; stage IIIB rectal cancer; stage IIIC rectal cancer; stage IVA rectal cancer; stage IVB rectal cancer

Outcome Measures

Primary Outcomes (2)

• Safety of the 4-peptide mixture

  Adverse events

  30 days following last vaccine

• Number of patients with an immune response to the peptides

  T cell responses against the peptides as measured in the sentinel immunized node

  through Day 22

Secondary Outcomes (1)

• Immunogenicity of the peptide mixture measured in the peripheral blood

  through Day 22

Study Arms (1)

Peptide Vaccine + Montanide + GM-CSF

EXPERIMENTAL

Colon peptide mixture (100 mcg each of the 4 peptides) plus 190 mcg of tetanus toxoid peptide, plus GM-CSF (110 mcg) in Montanide ISA-51 adjuvant

Biological: HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccine

Interventions

HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccine BIOLOGICAL

Peptide Vaccine + Montanide + GM-CSF

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of colorectal cancer * Stage IIB, III, or IV disease * HLA-A2- or -A3-positive PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 1,000/mm\^3 * Hemoglobin \> 9 g/dL * Platelet count \> 100,000/mm\^3 Hepatic * Liver function tests ≤ 2.5 times upper limit of normal (ULN) Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * No New York Heart Association class III or IV heart disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known or suspected allergies to any component of the study drug * No active connective tissue disease requiring medications * No systemic autoimmune disease with visceral involvement * No uncontrolled diabetes * No other severe autoimmune disease * No medical contraindication or potential problem that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * More than 30 days since prior immunotherapy * More than 30 days since prior growth factors * More than 30 days since prior allergy shots * No prior vaccination with any study peptides for malignancy Chemotherapy * More than 30 days since prior chemotherapy Endocrine therapy * More than 30 days since prior steroids Radiotherapy * More than 30 days since prior radiotherapy Surgery * More than 30 days since prior surgery Other * At least 30 days, but ≤ 24 months, since prior therapy for colorectal cancer * No concurrent illegal drug use

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

Sponsors & Collaborators

• Craig L Slingluff, Jr: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Receptor Protein-Tyrosine Kinases; Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cell Surface; Membrane Proteins; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors

Study Officials

• Charles M. Friel, MD

  University of Virginia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Human Immune Therapy Center

Study Record Dates

• First Submitted: September 7, 2004
• First Posted: September 9, 2004
• Study Start: March 24, 2003
• Primary Completion: February 15, 2008
• Study Completion: February 15, 2008
• Last Updated: March 30, 2020

Record last verified: 2020-03

Locations

US (1)