Status:
COMPLETED
Vaccination of Patients With Stage IV Melanoma With Dendritic Cells
Lead Sponsor:
Baylor Research Institute
Collaborating Sponsors:
Mary Crowley Medical Research Center
ODC Therapy
Conditions:
Melanoma
Neoplasm Metastasis
Eligibility:
All Genders
21-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to test a novel dendritic cell (DC) vaccine in patients with Stage IV melanoma.
Detailed Description
A novel dendritic cell vaccine has been developed at the Baylor Institute for Immunology Research (BIIR). Pre-clinical studies have found that this dendritic cell vaccine is more efficient in inducing...
Eligibility Criteria
Inclusion
- Stage M1a, M1b, M1c biopsy proven metastatic melanoma
- Failure of at least one prior chemotherapy regimen of DTIC and/or temozolomide with/without interleukin-2 (IL-2).
- Karnofsky performance status greater than/equal to 80%.
- Measurable metastatic lesions by physical exam or scans.
- Acceptable CBC and blood chemistry results
- Adequate renal function.
- Written informed consent.
Exclusion
- Patients who have received more than 8 cycles of chemotherapy for metastatic melanoma.
- Patients who have received chemotherapy less than 4 weeks before beginning the trial.
- Patients who have received interferon (IFN) alpha-2b or granulocyte-monocyte colony-stimulating factor (GM-CSF) less than 4 weeks before beginning the trial.
- Patients who have received high-dose IL-2 less than 4 weeks before beginning the trial.
- Patients with a history of central nervous system (CNS) metastatic melanoma.
- More than 5 hepatic lesions or any hepatic lesion larger than 5 cm.
- Baseline serum LDH greater than 4 times the upper limit of normal.
- Patients who are HIV positive.
- Patients who are pregnant.
- Patients who have received corticosteroids or other agents less than 4 weeks before beginning the trial.
- Patients with asthma, angina pectoris or congestive heart failure.
- Patients with autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.
- Patients with active infections including viral hepatitis.
- Patients with a history of any other neoplastic disease less than 5 years ago (carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin, however, can be admitted to the study).
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00125749
Start Date
July 1 2005
End Date
June 1 2007
Last Update
June 12 2017
Active Locations (1)
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1
Mary Crowley Medical Research Center: Baylor University Medical Center
Dallas, Texas, United States, 75246