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A Non-Randomized Multicenter Phase I/II Study Of Active Specific Immunotherapy In Patients With Stage II and Stage III Colon Cancer

Phase 1/Phase 2
21 Years
85 Years
Not Enrolling
Colorectal Cancer

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Trial Information

A Non-Randomized Multicenter Phase I/II Study Of Active Specific Immunotherapy In Patients With Stage II and Stage III Colon Cancer


- Determine safety and immunogenicity of adjuvant autologous tumor cell vaccine in
patients with completely resected stage II or III adenocarcinoma of the colon.

OUTLINE: This is a multicenter study. Patients are stratified according to disease stage (II
vs III).

Beginning 28-35 days after total surgical resection, patients receive adjuvant autologous
tumor cell vaccine intradermally once weekly for 3 vaccinations. The first 2 vaccinations
also contain BCG. Patients with stage II disease receive a fourth vaccination 6 months after
surgical resection.

Beginning 10-17 days after the third vaccination, patients with stage III disease receive
adjuvant leucovorin calcium IV and fluorouracil IV on days 1-5. Chemotherapy continues every
28-35 days for a total of 6 courses. These patients also receive a fourth vaccination 1
month after the completion of chemotherapy.

Patients are followed at 90 days and 6 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed stage II or III primary adenocarcinoma of the colon

- Completely resected within the past 28-35 days, at which time tumor tissue is
harvested for vaccine production

- No residual or metastatic disease

- No more than 1 malignant invasive primary colon cancer

- No tumor originating in the rectum (i.e., inferior tumor margin must not be at or
below the peritoneal reflection)

- No perforated tumors



- 21 to 85

Performance status:

- WHO 0-1

Life expectancy:

- Not specified


- WBC greater than 4,000/mm^3

- Platelet count greater than 100,000/mm^3

- Hemoglobin greater than 10.0 g/dL


- Bilirubin normal

- SGOT normal

- Alkaline phosphatase normal

- No severe hepatic disease that would preclude study


- Creatinine less than 1.5 times upper limit of normal

- No severe renal disease that would preclude study


- No prosthetic cardiac valves

- No recent vascular prosthesis

- No postsurgical cardiovascular complication

- No severe cardiovascular disease that would preclude study


- No postsurgical pulmonary complication


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No insulin-dependent diabetes mellitus

- No severe systemic disease that would preclude study

- No congenital or acquired immune deficiency disease

- No history of chronic ulcerative colitis, Crohn's disease, Gardner's syndrome, or
Turcot's syndrome

- No ileus

- No other prior malignancy except curatively treated squamous cell or basal cell skin
cancer or carcinoma in situ of the cervix

- No ongoing infection requiring systemic antibiotics

- No severe postoperative complication that would preclude study

- Carcinoembryonic antigen normal


Biologic therapy:

- No other concurrent investigational immunotherapy


- No prior systemic chemotherapy

- No other concurrent investigational chemotherapy

Endocrine therapy:

- No concurrent steroids


- No prior radiotherapy

- No concurrent investigational radiotherapy


- See Disease Characteristics

- No concurrent investigational surgery


- At least 3 weeks since prior systemic antibiotic therapy of more than 5 days duration
(excluding topical antibiotics or perioperative prophylactic antibiotics)

- No concurrent cytotoxic immunosuppressive agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael G Hanna Jr., PhD

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Federal Government

Study ID:




Start Date:

March 2001

Completion Date:

August 2004

Related Keywords:

  • Colorectal Cancer
  • stage II colon cancer
  • stage III colon cancer
  • adenocarcinoma of the colon
  • Colonic Neoplasms
  • Colorectal Neoplasms



Inova Fairfax Hospital Falls Church, Virginia  22042-3300
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital Allentown, Pennsylvania  18105