Clinical trial NCT00091286: Vaccine Therapy in Treating Patients With Stage IIB, Stage III, or Stage IV Colorectal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
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
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-09-09
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Safety of the 4-peptide mixture
timeFrame: 30 days following last vaccine
measure: Number of patients with an immune response to the peptides
timeFrame: through Day 22
Secondary outcomes:
measure: Immunogenicity of the peptide mixture measured in the peripheral blood
timeFrame: through Day 22
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Cancer Center
state: Virginia
Study officials:
affiliation: University of Virginia
name: Charles M. Friel, MD
role: STUDY_CHAIR
References: