Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer

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: NCT00019591
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 20, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Vaccines may make the body build an immune response that will kill cancer cells. Combining vaccine therapy with interleukin-2 may kill more cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have locally advanced or metastatic colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: aldesleukin Biological: ras peptide cancer vaccine Procedure: adjuvant therapy Phase 1 Phase 2

Detailed Description:


  • Determine the frequency of immunologic response in patients with locally advanced or metastatic colorectal cancer treated with ras peptide-pulsed dendritic cell vaccine with or without interleukin-2.
  • Determine the tumor response and survival time in patients with metastatic colorectal cancer treated with vaccine plus interleukin-2.
  • Determine the time to progression in patients with locally advanced colorectal cancer treated with adjuvant vaccine.

OUTLINE: Patients are assigned to 1 of 2 treatment groups according to extent of disease. Patients with prior locally advanced disease are assigned to treatment group A, while those with metastatic disease are assigned to treatment group B.

  • Group A: Patients are vaccinated against influenza on day -6. Patients undergo collection of peripheral blood mononuclear cells (PBMC) on day -4. The PBMC are cultured with sargramostim (GM-CSF) and interleukin-4 for 5 days and CD40 ligand for 24 hours and then pulsed for 2 hours with the appropriate peptide to form a vaccine. Patients receive ras peptide-pulsed dendritic cell vaccine IV over 5 minutes on days 1, 15, 29, 43, and 57.
  • Group B: Patients undergo collection of PBMC and receive vaccination as in group A. Patients also receive interleukin-2 subcutaneously on days 2-6 and 9-13.

Treatment in both groups repeats every 2 weeks for up to 5 vaccinations in the absence of disease progression or unacceptable toxicity.

Patients are followed on days 75, 90, 120, and 365.

PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 3 years.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of Vaccination With Mutant Ras Peptide-Pulsed Dendritic Cells in the Treatment of HLA A2.1 Positive Patients With Colorectal Cancer
Study Start Date : March 1999
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Response rate every 3 months for up to a year after completion of study treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed locally advanced or metastatic colorectal cancer
  • Metastatic disease must be radiologically proven
  • HLA-A2-1 positive
  • Locally advanced disease must have had prior resection or incomplete resection with poor prognosis
  • Locally advanced disease includes:

    • Stage III or IV colon cancer (T4 or any T, N2-3, M0)
    • Stage III or IV rectal cancer (T4 or T3, N1-3)
    • Resectable or unresectable T4 disease after radiotherapy, chemotherapy, and/or surgery
    • Absence of measurable disease but more than a 50% chance of recurrence
  • Completely resected or locally advanced disease may have had conventional therapy completed within 1-12 months (surgery alone, with or without adjuvant chemotherapy and/or radiotherapy) prior to study entry
  • Metastatic disease patients must have bidimensionally measurable disease

    • Bone lesions with well-demarcated borders allowed
    • Lesions seen only on bone scan, pleural effusions, ascites, and changes in carcinoembryonic antigen are not considered measurable disease



  • Over 18

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified


  • Lymphocyte count at least 470/mm^3
  • Granulocyte count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 2.0 mg/dL*
  • SGOT no greater than 4 times upper limit of normal (ULN) (2.5 times ULN for adjuvant patients)*
  • Albumin at least 3 g/dL
  • No active viral hepatitis
  • No evidence of chronic infection due to hepatitis C
  • Hepatitis B surface antigen negative NOTE: *Unless due to metastatic disease


  • Creatinine no greater than 2.0 mg/dL


  • No history of cardiac failure, significant arrhythmias, or coronary artery disease (metastatic disease patients only)


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No prior malignancy with a 50% chance of recurrence within 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
  • No medical or psychiatric condition that would preclude compliance
  • No serious medical condition that would preclude apheresis
  • No serious infection
  • No uncontrolled thyroid disease (metastatic disease patients only)
  • Patients with an allergy to eggs are allowed but are not vaccinated against influenza during study


Biologic therapy:

  • No prior immunologic therapy directed at the cellular immune system


  • See Disease Characteristics
  • Prior chemotherapy for metastatic disease allowed
  • At least 4 weeks since prior chemotherapy
  • No concurrent chemotherapy or anticipated need for chemotherapy for 2 months after vaccinations

Endocrine therapy:

  • At least 4 weeks since prior supraphysiologic steroid therapy


  • See Disease Characteristics
  • Prior radiotherapy for metastatic disease allowed
  • No concurrent radiotherapy


  • See Disease Characteristics
  • Prior surgery for metastatic disease allowed

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): NCT00019591

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
National Cancer Institute (NCI)
Study Chair: John E. Janik, MD NCI - Metabolism Branch;MET Identifier: NCT00019591     History of Changes
Obsolete Identifiers: NCT00001794
Other Study ID Numbers: CDR0000066874
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: November 2005

Keywords provided by National Cancer Institute (NCI):
stage III colon cancer
stage IV colon cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents