Status:
COMPLETED
Vaccine Therapy and GM-CSF in Treating Patients With Recurrent or Metastatic Melanoma
Lead Sponsor:
Hoag Memorial Hospital Presbyterian
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief 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, increas...
Detailed 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 irradiat...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00436930
Start Date
December 1 2006
End Date
October 1 2012
Last Update
January 10 2014
Active Locations (1)
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1
Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663