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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.
Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
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
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.

Study Phase Phase I, Phase II
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Colorectal Cancer
Intervention  Drug: BCG vaccine
Drug: autologous tumor cell vaccine
Drug: fluorouracil
Drug: leucovorin calcium
Procedure: adjuvant therapy
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  March 2001
Completion Date
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
Gender Both
Ages 21 Years to 85 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00016133
Organization ID CDR0000068597
Secondary IDs †† INTRACEL-ASI-2002
Study Sponsor  Intracel
Collaborators ††
Investigators 
Study Chair:     Michael G Hanna Jr., PhD     Intracel    
Information Provided By National Cancer Institute (NCI)
Verification Date July 2004
First Received Date  May 6, 2001
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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