Vaccine Biotherapy of Cancer: Autologous Tumor Cells and Dendritic Cells
Completed · Phase 2
Conditions studied: Metastatic Melanoma
In brief
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 received subcutaneous (s.c.) injections of irradiated autologous tumor cells that had been established as short-term cell lines, in conjunction with their own dendritic cells (DC) and granulocyte macrophage colony-stimulating factor \[GM-CSF\]. Eligible patients had regionally recurrent and/or distant metastatic cancer.
Key facts
- Study ID
- NCT00948480
- Run by
- Hoag Memorial Hospital Presbyterian
- People needed
- 56
- Starts
- 2000-10-01
- Expected to finish
- 2007-09-01
- Last updated by the study team
- 2016-07-15
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
Full record on ClinicalTrials.gov
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