Tumor-Pulsed Dendritic Cells Used as a Tumor Vaccine

NCT00176761 | Terminated Phase 2

• 2 other identifiers: UMCC 9947GCRC Protocol #1673
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• To assess the antitumor response of this immunotherapy regimen.

Secondary Outcomes (2)

• 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.

• To evaluate the toxicity of this treatment regimen.

Interventions

Interleukin-2 (IL-2) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have metastatic colorectal cancer. Patients are eligible whether they are previously untreated or had received prior treatment.
• 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.
• Karnofsky performance status equal to or greater than 70%.
• Life expectancy of at least three months.
• 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.
• Adequate baseline hematopoietic function:
• platelet count equal to or greater than 100,000/mm3
• total white blood count equal to or greater than 3,000/mm3
• 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).
• Patients must not have received irradiation for the four weeks prior to entry onto the study.
• Ability to give informed consent.

You may not qualify if:

• Patients may not have received prior antitumor vaccines.
• History of any autoimmune diseases (e.g. SLE, rheumatoid arthritis, myasthenia gravis).
• Active infection (bacterial, fungal, or viral), or active bleeding (e.g. hemoptysis, GI bleeding).
• Pregnancy or lactation; women of childbearing potential and men must use effective contraception during the course of this clinical trial.
• Uncontrolled angina, arrhythmias, bronchospasm, hypertension, hyperglycemia or hypercalcemia.
• History of corticosteroid use in the four weeks preceding entry onto the clinical study.
• Patients who require corticosteroids.
• Evidence of HIV infection or AIDS and/or testing positive for HBSAg.
• Any medical or psychiatric illness which in the opinion of the clinical investigators would compromise the patients ability to tolerate this treatment.
• Patients who require anticoagulation.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• University of Michigan: collaborator

Study Sites (1)

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Mark Zalupski, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: March 1, 2000
• Study Completion: May 1, 2006
• Last Updated: September 11, 2006

Record last verified: 2006-09

Locations

US (1)