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Trial record 26 of 176 for:    immunotherapeutic agent | colon cancer

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00016133
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 30, 2013
Information provided by:
National Cancer Institute (NCI)

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.

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

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
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
Study Start Date : March 2001
Actual Study Completion Date : August 2004

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00016133

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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
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Study Chair: Michael G Hanna Jr., PhD Intracel

Layout table for additonal information Identifier: NCT00016133     History of Changes
Other Study ID Numbers: INTRACEL-ASI-2002
CDR0000068597 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: July 2004
Keywords provided by National Cancer Institute (NCI):
stage II colon cancer
stage III colon cancer
adenocarcinoma of the colon
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Physiological Effects of Drugs
Antineoplastic Agents
Immunosuppressive Agents
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
BCG Vaccine
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Adjuvants, Immunologic