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

Sponsored by Craig L Slingluff, Jr

About this trial

Last updated 5 years ago

Study ID

9976

Status

Terminated

Type

Interventional

Phase

Early Phase 1

Placebo

No

Accepting

18-75 Years
18 to 120 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 17 years ago

What is this trial about?

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.

What are the Participation Requirements?

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

Locations

Location

Status