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

NCT00016133 | Completed Phase 1

• 2 other identifiers: INTRACEL-ASI-2002CDR0000068597
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy combined with leucovorin and fluorouracil in treating patients who have undergone surgery to completely remove stage II or stage III colon cancer.

Conditions

Colorectal Cancer

Keywords

stage II colon cancer; stage III colon cancer; adenocarcinoma of the colon

Interventions

BCG vaccine BIOLOGICAL

autologous tumor cell vaccine BIOLOGICAL

fluorouracil DRUG

leucovorin calcium DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 PATIENT CHARACTERISTICS: Age: * 21 to 85 Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * WBC greater than 4,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * 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 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Intracel: lead

Study Sites (2)

John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital

Allentown, Pennsylvania, 18105-1556, United States

Location

Inova Fairfax Hospital

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

BCG Vaccine; FANG vaccine; Fluorouracil; Leucovorin; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Michael G Hanna Jr., PhD

  Intracel

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 6, 2001
• First Posted: January 27, 2003
• Study Start: March 1, 2001
• Study Completion: August 1, 2004
• Last Updated: May 30, 2013

Record last verified: 2004-07

Locations

US (2)