Vaccine Therapy and GM-CSF in Treating Patients With Recurrent or Metastatic Melanoma
| Status: | Recruiting |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 16 - Any |
| Updated: | 1/1/2014 |
| Start Date: | December 2006 |
Randomized Phase II Trial of Autologous Vaccines Consisting of Adjuvant GM-CSF Plus Proliferating Tumor Cells Versus GM-CSF Plus Dendritic Cells Loaded With Proliferating Tumor Cells in Patients With Metastatic Melanoma (MAC-VAC)
RATIONALE: Vaccines made from a person's tumor cells and white blood cells may help the body
build an effective immune response to kill tumor cells. Colony-stimulating factors, such as
GM-CSF, increase the number of white blood cells and platelets found in bone marrow or
peripheral blood. Giving vaccine therapy together with GM-CSF may be an effective treatment
for melanoma.
PURPOSE: This randomized phase II trial is studying two different vaccine therapy regimens
to compare how well they work when given together with GM-CSF in treating patients with
recurrent or metastatic melanoma.
build an effective immune response to kill tumor cells. Colony-stimulating factors, such as
GM-CSF, increase the number of white blood cells and platelets found in bone marrow or
peripheral blood. Giving vaccine therapy together with GM-CSF may be an effective treatment
for melanoma.
PURPOSE: This randomized phase II trial is studying two different vaccine therapy regimens
to compare how well they work when given together with GM-CSF in treating patients with
recurrent or metastatic melanoma.
OBJECTIVES:
- Compare overall survival, progression-free survival, event-free survival, and
failure-free survival of patients with metastatic melanoma treated with vaccine therapy
comprising irradiated autologous tumor cells vs autologous dendritic cells loaded with
irradiated autologous tumor cells in combination with sargramostim (GM-CSF).
- Compare the frequency of immune response based on delayed-type hypersensitivity to
irradiated autologous tumor cells and serologic and cellular assays at baseline and
during and after completion of autologous tumor cell-based vaccine therapy in these
patients.
- Compare the safety of these regimens in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to measurable disease
(yes vs no) and location of disease (distant vs regional). Patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients receive irradiated autologous tumor cells subcutaneously (SC) and
sargramostim (GM-CSF) SC once weekly for 3 weeks and then once monthly for up to 5
months in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive autologous dendritic cells loaded with irradiated autologous
tumor cells SC and GM-CSF SC once weekly for 3 weeks and then once monthly for up to 5
months in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
- Compare overall survival, progression-free survival, event-free survival, and
failure-free survival of patients with metastatic melanoma treated with vaccine therapy
comprising irradiated autologous tumor cells vs autologous dendritic cells loaded with
irradiated autologous tumor cells in combination with sargramostim (GM-CSF).
- Compare the frequency of immune response based on delayed-type hypersensitivity to
irradiated autologous tumor cells and serologic and cellular assays at baseline and
during and after completion of autologous tumor cell-based vaccine therapy in these
patients.
- Compare the safety of these regimens in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to measurable disease
(yes vs no) and location of disease (distant vs regional). Patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients receive irradiated autologous tumor cells subcutaneously (SC) and
sargramostim (GM-CSF) SC once weekly for 3 weeks and then once monthly for up to 5
months in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive autologous dendritic cells loaded with irradiated autologous
tumor cells SC and GM-CSF SC once weekly for 3 weeks and then once monthly for up to 5
months in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
- Diagnosis of melanoma
- Regionally recurrent or distant metastatic disease
- Must have an established continuously proliferating cell line expanded to about 200
million cells that is free of stromal cells and contamination
- No active CNS metastases
- Prior treatment for brain metastases or spinal cord compression allowed
- No clear evidence of disease progression in the CNS
- No concurrent pharmacologic doses of corticosteroids
PATIENT CHARACTERISTICS:
- Karnofsky performance status (PS) 70-100% OR ECOG PS 0-1
- Platelet count > 100,000/mm³
- Hematocrit > 30%
- Creatinine < 2.0 mg/dL
- Bilirubin < 2.0 mg/dL
- Albumin > 3.0 mg/dL
- No significant hepatic or renal dysfunction
- No other invasive cancer within the past 5 years
- No active infection or other active medical condition that could be eminently life
threatening, including any of the following:
- Active blood clotting
- Bleeding diathesis
- No ongoing transfusion requirement
- No underlying cardiac disease associated with known myocardial dysfunction
- No unstable angina related to atherosclerotic cardiovascular disease
- No known autoimmune disease
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
- Prior surgery, radiotherapy, chemotherapy, biological therapy (including sargramostim
[GM-CSF]), or vaccine therapy allowed
- No concurrent anticancer therapy (e.g., hormone therapy for prostate or breast
cancer)
- No concurrent digoxin or other medications for the treatment of heart failure
- No concurrent immunosuppressive therapy
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