Tumor-Pulsed Dendritic Cells Used as a Tumor Vaccine - Full Text View

Purpose

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	Intervention	Phase
Metastatic Colorectal Cancer	Drug: Interleukin-2 (IL-2)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:

To assess the antitumor response of this immunotherapy regimen.

Secondary Outcome Measures:

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.

Estimated Enrollment:	27
Study Start Date:	March 2000
Estimated Study Completion Date:	May 2006

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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:
1. platelet count equal to or greater than 100,000/mm3
2. 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.

Exclusion Criteria

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.
There is no exclusion for sex or ethnic background.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00176761

Locations

United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan Cancer Center

University of Michigan

Investigators

Principal Investigator:

Mark Zalupski, M.D.

University of Michigan Cancer Center

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00176761 History of Changes
Other Study ID Numbers:	UMCC 9947, GCRC Protocol #1673
Study First Received:	September 9, 2005
Last Updated:	September 6, 2006
Health Authority:	United States: Food and Drug Administration United States: University of Michigan Data Safety Monitoring Board United States: University of Michigan Quality Assurance Review Committee

Additional relevant MeSH terms:

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

Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013