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Evaluation of the Immunogenicity of Vaccination With HER-2/Neu and CEA Derived Synthetic Peptides With GM-CSF-in-Adjuvant, in Patients With Stage IIB, III, or IV Colorectal Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

Evaluation of the Immunogenicity of Vaccination With HER-2/Neu and CEA Derived Synthetic Peptides With GM-CSF-in-Adjuvant, in Patients With Stage IIB, III, or IV Colorectal Cancer


OBJECTIVES:

- Determine whether vaccination comprising HER-2-neu and carcinoembryonic antigen
synthetic peptides, sargramostim (GM-CSF), and Montanide ISA-51 causes an immune
response in patients with stage IIB, III, or IV colorectal cancer.

- Determine the safety of this regimen in these patients.

OUTLINE: Patients receive vaccination comprising HER-2-neu and carcinoembryonic antigen
synthetic peptides, sargramostim (GM-CSF), and Montanide ISA-51 on days 1, 8, and 15. On day
22, patients undergo removal of the lymph node into which the vaccination site drains to
determine whether the immune system is responding to the vaccine.

PROJECTED ACCRUAL: A maximum of 15 patients will be accrued for this study.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of the 4-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity at day 22

Safety Issue:

Yes

Principal Investigator

Charles M. Friel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Virginia

Authority:

United States: Federal Government

Study ID:

CDR0000386177

NCT ID:

NCT00091286

Start Date:

March 2003

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • 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
  • Colorectal Neoplasms

Name

Location

University of Virginia Cancer CenterCharlottesville, Virginia  22908