Vaccine Biotherapy of Cancer: Autologous Tumor Cells and Dendritic Cells

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vaccine Biotherapy Of Cancer: Autologous Tumor Cells and Dendritic Cells as Active Specific Immunotherapy in Patients With Metastatic Melanoma

Conditions
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Metastatic Melanoma

Intervention / Treatment
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* Biological: Autologous tumor cells plus dendritic cells
* Drug: GM-CSF


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Autologous tumor cells plus dendritic cells|A series of 8 vaccinations are administered over 6 months|
|Drug: GM-CSF|500 mcg|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| event-free survival [death or disease progression] |  | 5.5 years after treatment initation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 5.5 years after treatment initation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autologous tumor cell vaccine, metastatic melanoma, sargramostim (GM-CSF)