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Colorectal CancerPhase 1/2NCT00016133

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

A Phase 1/2 study testing BCG vaccine, autologous tumor cell vaccine and fluorouracil in people with Colorectal Cancer, run by Intracel at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 85 years
Conditions the study is for
Colorectal Cancer
What is being tested?
BCG vaccine, autologous tumor cell vaccine and fluorouracil
Type of treatment
Vaccines, Surgery or procedure
How many people
Not given
Where
2 sitesUnited States
Study dates
Mar 2001to Aug 2004
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital

    Allentown, Pennsylvania, 18105-1556

  • Inova Fairfax Hospital

    Fairfax, Virginia, 22031

Other trials in United States

About this study

Official title: A Non-Randomized Multicenter Phase I/II Study Of Active Specific Immunotherapy In Patients With Stage II and Stage III Colon Cancer

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.

Being tested
BCG vaccine, autologous tumor cell vaccine, fluorouracil, leucovorin calcium, adjuvant therapy
Keywords
stage II colon cancer, stage III colon cancer, adenocarcinoma of the colon
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startMar 2001
  3. Study completionAug 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00016133
Sponsor's protocol ID
INTRACEL-ASI-2002
Other IDs
CDR0000068597
Status last verified
Jul 2004
First submitted
6 May 2001
Last updated
30 May 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BCG vaccine, autologous tumor cell vaccine and fluorouracil in people with Colorectal Cancer, run by Intracel at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2013.

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