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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BCG vaccine
autologous tumor cell vaccine
fluorouracil
leucovorin calcium
adjuvant therapy
Sponsored by
Intracel
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage II colon cancer, stage III colon cancer, adenocarcinoma of the colon

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
  • Inova Fairfax Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2001
Last Updated
May 29, 2013
Sponsor
Intracel
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1. Study Identification

Unique Protocol Identification Number
NCT00016133
Brief Title
Vaccine Therapy in Treating Patients With Stage II or Stage III Colon Cancer That Has Been Removed During Surgery
Official Title
A Non-Randomized Multicenter Phase I/II Study Of Active Specific Immunotherapy In Patients With Stage II and Stage III Colon Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2004
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Intracel

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage II colon cancer, stage III colon cancer, adenocarcinoma of the colon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
BCG vaccine
Intervention Type
Biological
Intervention Name(s)
autologous tumor cell vaccine
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael G Hanna Jr., PhD
Organizational Affiliation
Intracel
Official's Role
Study Chair
Facility Information:
Facility Name
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105-1556
Country
United States
Facility Name
Inova Fairfax Hospital
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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