Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy in Treating Patients With Stage II or Stage III Colon Cancer That has Been Removed During Surgery

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Completed	21 to 85	Pharmaceutical / Industry	INTRACEL-ASI-2002 NCT00016133

Objectives

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

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy:

• No other concurrent investigational immunotherapy

Chemotherapy:

• No prior systemic chemotherapy
• No other concurrent investigational chemotherapy

Endocrine therapy:

• No concurrent steroids

Radiotherapy:

• No prior radiotherapy
• No concurrent investigational radiotherapy

Surgery:

• See Disease Characteristics
• No concurrent investigational surgery

Other:

• 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

Patient Characteristics:

Age:

• 21 to 85

Performance status:

• WHO 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 4,000/mm³
• Platelet count greater than 100,000/mm³
• Hemoglobin greater than 10.0 g/dL

Hepatic:

• Bilirubin normal
• SGOT normal
• Alkaline phosphatase normal
• No severe hepatic disease that would preclude study

Renal:

• Creatinine less than 1.5 times upper limit of normal
• No severe renal disease that would preclude study

Cardiovascular:

• No prosthetic cardiac valves
• No recent vascular prosthesis
• No postsurgical cardiovascular complication
• No severe cardiovascular disease that would preclude study

Pulmonary:

• No postsurgical pulmonary complication

Other:

• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Intracel Resources, LLC

Michael G Hanna Jr., PhD, Protocol chair		Ph: 301-668-8400

Registry Information
Official Title		A Non-Randomized Multicenter Phase I/II Study Of Active Specific Immunotherapy In Patients With Stage II and Stage III Colon Cancer
Trial Start Date		2001-03-08
Registered in ClinicalTrials.gov		NCT00016133
Date Submitted to PDQ		2001-03-12
Information Last Verified		2004-07-16

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