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CompletedNCT00016133Updated May 30, 2013

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

A Phase 1/2 interventional study of BCG vaccine and autologous tumor cell vaccine in Colorectal Cancer, sponsored by Intracel. Completed at 2 sites in United States. Open to participants aged 21 Years to 85 Years. Per ClinicalTrials.gov, last updated 2013-05-30.

Sponsored by Intracel · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Ages
21 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • stage II colon cancer
  • stage III colon cancer
  • adenocarcinoma of the colon
03

In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

Browse Colorectal Neoplasms studies →

Lead sponsor

Intracel is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 85 Years
Sexes eligible
All
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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment

Interventions

06

Study locations

2 sites
  • John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
    Allentown, Pennsylvania 18105-1556, United States
  • Inova Fairfax Hospital
    Fairfax, Virginia 22031, United States
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2001 and a completion of Aug 2004. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 6, 2001
First posted
Jan 27, 2003
Start
Mar 2001
CompletionActual
Aug 2004
Last update
May 30, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00016133
Lead sponsor
Intracel
First posted
Jan 27, 2003
Start date
Mar 2001
Completion
Aug 2004
Last update
May 30, 2013

Study contacts

Michael G Hanna Jr., PhD
study chair · Intracel
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2004. You cannot join it, but the record below documents what was studied.

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