Status:
COMPLETED
Vaccine Biotherapy of Cancer: Autologous Tumor Cells and Dendritic Cells
Lead Sponsor:
Hoag Memorial Hospital Presbyterian
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
This protocol was conducted as a single institution trial at Hoag Cancer Center, Hoag Hospital, Newport Beach, California. It was a single-arm phase II trial in which patients with metastatic melanoma...
Detailed Description
Patients were stratified by whether they had no measurable disease \[NMD\] at the time of treatment (usually because of surgical resection of metastases), or whether they had objectively measurable di...
Eligibility Criteria
Inclusion
- Recurrent or metastatic melanoma as defined by stage IV disease (distant metastases), or any recurrent melanoma manifested by lymph node metastases or soft tissue nodules
- ECOG Performance status of 0-2
- Satisfactory medical condition for treatment in a phase I-II trial of anticancer therapy
- Age \> 16 years
- Venous access for leukopheresis procedure to obtain peripheral blood lymphocytes to generate dendritic cells.
- Serum pregnancy test must be negative for women of childbearing potential.
Exclusion
- Active central nervous system metastases
- Known autoimmune disease or disease process that involves the use of immunosuppressive therapy.
- Underlying cardiac disease associated with New York Heart Association class III or IV function, or unstable angina related to atherosclerotic cardiovascular disease.
- Ongoing transfusion requirements, no significant hepatic or renal dysfunction, creatinine \< 2.0 mg/dl, bilirubin \< 2.0 mg/dl, albumin \> 3.0 mg/dl, hematocrit \> 25, platelets \> 100,000.
- Active infection or other active medical condition that could be eminently life threatening, including no active blood clotting or bleeding diathesis.
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00948480
Start Date
October 1 2000
End Date
September 1 2007
Last Update
July 15 2016
Active Locations (1)
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1
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658