Melanoma Clinical Trial

Vaccine Therapy and GM-CSF in Treating Patients With Recurrent or Metastatic Melanoma

Summary

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.

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Full Description

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.

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Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

200

Study ID:

NCT00436930

Recruitment Status:

Completed

Sponsor:

Hoag Memorial Hospital Presbyterian

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There is 1 Location for this study

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Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian
Newport Beach California, 92663, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

200

Study ID:

NCT00436930

Recruitment Status:

Completed

Sponsor:


Hoag Memorial Hospital Presbyterian

How clear is this clinincal trial information?

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