Vaccine Biotherapy of Cancer: Autologous Tumor Cells and Dendritic Cells

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoag Memorial Hospital Presbyterian
• Treatments: Sargramostim; Vaccines

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.