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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00016133
First received: May 6, 2001
Last updated: May 29, 2013
Last verified: July 2004
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Biological: BCG vaccine
Biological: autologous tumor cell vaccine
Drug: fluorouracil
Drug: leucovorin calcium
Procedure: adjuvant therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Non-Randomized Multicenter Phase I/II Study Of Active Specific Immunotherapy In Patients With Stage II and Stage III Colon Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2001
Study Completion Date: August 2004
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.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00016133

Locations
United States, Pennsylvania
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105-1556
United States, Virginia
Inova Fairfax Hospital
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Intracel
Investigators
Study Chair: Michael G Hanna Jr., PhD Intracel
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00016133     History of Changes
Other Study ID Numbers: INTRACEL-ASI-2002, CDR0000068597
Study First Received: May 6, 2001
Last Updated: May 29, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II colon cancer
stage III colon cancer
adenocarcinoma of the colon

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Fluorouracil
Levoleucovorin
Antidotes
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014