Metastatic Melanoma
Conditions
Keywords
autologous tumor cell vaccine, metastatic melanoma, sargramostim (GM-CSF)
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 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.
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 disease (OMD) by physical examination or radiologic scans per response evaluation criteria in solid tumors (RECIST criteria). Key endpoints were the results of delayed type hypersensitivity (DTH) skin testing to their own irradiated tumor cells, event-free survival \[death or disease progression\], overall survival, and objective tumor regression in patients who have measurable disease at the time vaccine therapy was initiated. This study was activated in the fall of 2000, and closed to accrual in June 2007.
Interventions
BIOLOGICALAutologous tumor cells plus dendritic cells
A series of 8 vaccinations are administered over 6 months
DRUGGM-CSF
500 mcg
Sponsors
Hoag Memorial Hospital Presbyterian
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| event-free survival [death or disease progression] | 5.5 years after treatment initation |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 5.5 years after treatment initation |
Countries
United States
Outcome results
None listed