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Tumor-Pulsed Dendritic Cells Used as a Tumor Vaccine

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: NCT00176761
Recruitment Status : Terminated
First Posted : September 15, 2005
Last Update Posted : September 11, 2006
University of Michigan
Information provided by:
University of Michigan Rogel Cancer Center

Brief Summary:
This study is being conducted to determine the efficacy, side effects, and toxicity of an investigational vaccine that consists of tumor-pulsed dendritic cells administered with an immune stimulating drug called interleukin-2 (IL-2). Dendritic cells are immune cells that are obtained from a subject's blood and are important in the body’s immune response to foreign substances. This study will examine the response of a subject's immune system after receiving several vaccinations containing their own dendritic cells which have been exposed to dead fragments of their cancer cells in the laboratory. This may result in sensitizing a subject's dendritic cells to their cancer cells so that their dendritic cells will react with other cells of the immune system and attack the cancer. It has been shown in the laboratory that dendritic cells exposed to cancer cell fragments can provide lymphocytes (a type of white blood cell) with signals they require in order to become fully activated and acquire the ability to kill cancer cells.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Interleukin-2 (IL-2) Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Assessing Autologous, Tumor-Pulsed Dendritic Cells as a Tumor Vaccine Administered With IL-2 in Patients With Metastatic Colorectal Cancer
Study Start Date : March 2000
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To assess the antitumor response of this immunotherapy regimen.

Secondary Outcome Measures :
  1. To characterize the immune response (as defined in Section VII) to the tumor-pulsed dendritic cell vaccine combined with IL-2 administration in patients with metastatic colorectal cancer.
  2. To evaluate the toxicity of this treatment regimen.

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

Inclusion Criteria:

  1. Patients must have metastatic colorectal cancer. Patients are eligible whether they are previously untreated or had received prior treatment.
  2. Patients must have a source of autologous tumor that can be easily harvested. This includes patients with subcutaneous or cutaneous metastases, patients with easily excisable lymph nodes containing metastatic tumor, and patients with malignant pleural effusions or ascites. In addition, some patients who undergo a planned curative operation are found at that time of surgery to be unresectable and these patients could have a sample of tumor resected at that time to be eligible for this study.
  3. Karnofsky performance status equal to or greater than 70%.
  4. Life expectancy of at least three months.
  5. Patients must have evaluable or measurable disease in addition to the disease that will be surgically removed for the purposes of formulating the autologous vaccine.
  6. Adequate baseline hematopoietic function:

    1. platelet count equal to or greater than 100,000/mm3
    2. total white blood count equal to or greater than 3,000/mm3
  7. Patients must not have received any antineoplastic chemotherapy or immunotherapy for the four weeks preceding entry onto the study (six weeks for nitrosoureas and mitomycin-C).
  8. Patients must not have received irradiation for the four weeks prior to entry onto the study.
  9. Ability to give informed consent.

Exclusion Criteria

  1. Patients may not have received prior antitumor vaccines.
  2. History of any autoimmune diseases (e.g. SLE, rheumatoid arthritis, myasthenia gravis).
  3. Active infection (bacterial, fungal, or viral), or active bleeding (e.g. hemoptysis, GI bleeding).
  4. Pregnancy or lactation; women of childbearing potential and men must use effective contraception during the course of this clinical trial.
  5. Uncontrolled angina, arrhythmias, bronchospasm, hypertension, hyperglycemia or hypercalcemia.
  6. History of corticosteroid use in the four weeks preceding entry onto the clinical study.
  7. Patients who require corticosteroids.
  8. Evidence of HIV infection or AIDS and/or testing positive for HBSAg.
  9. Any medical or psychiatric illness which in the opinion of the clinical investigators would compromise the patients ability to tolerate this treatment.
  10. Patients who require anticoagulation.
  11. There is no exclusion for sex or ethnic background.

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): NCT00176761

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United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
University of Michigan
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Principal Investigator: Mark Zalupski, M.D. University of Michigan Rogel Cancer Center
Layout table for additonal information Identifier: NCT00176761    
Other Study ID Numbers: UMCC 9947
GCRC Protocol #1673
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: September 11, 2006
Last Verified: September 2006
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs