Status:
TERMINATED
Tumor-Pulsed Dendritic Cells Used as a Tumor Vaccine
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborating Sponsors:
University of Michigan
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Detailed Description
Pretreatment screening: If a subject decides to participate in this study they will first be presented the informed consent document to read and review with the Principal Investigator (or his designee...
Eligibility Criteria
Inclusion
- 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:
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00176761
Start Date
March 1 2000
End Date
May 1 2006
Last Update
September 11 2006
Active Locations (1)
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1
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109