A FEASIBILITY AND TOXICITY STUDY OF A GM-CSF SECRETING ALLOGENEIC MELANOMA VACCINE ADMINISTERED ALONE OR IN COMBINATION WITH CYCLOPHOSPHAMIDE IN SUBJECTS WITH SURGICALLY RESECTED AT-RISK MELANOMA
This research study is being done to determine if the investigational vaccine â?? Melanoma GVAX is generally safe, tolerable and effective in people with Stage IIB-IV, surgically resected Melanoma. This clinical trial is being conducted to find out what effects, good and bad; GVAX has on your type of cancer and how effective it is against your stage of Melanoma. GVAX is an allogenic (genetically different) GM-CSF secreting â??killedâ?? whole melanoma cell vaccine. The vaccine will be given alone or in combination with low dose Cyclophosphamide, a standard chemotherapy drug. This study will also assess the blood levels, cellular immune responses and serology of anti-melanoma immunization by melanoma GVAX. The results of these tests will not affect clinical care.
Adult patientâ??s â?¥18 yrs old, with Stage IIB, IIC, III, IV cutaneous or mucosal melanoma, that has been completely resected.* the most recent surgery where melanoma was detected is between 2 weeks and 6 months. * Must be active, have adequate hematologic, renal, liver function. * using effective birth control and to continue to use effective birth control for four weeks after the last treatment * no anticancer treatment for 4 weeks or surgery for 2 weeks before treatment starts * No active infections such as: coagulation disorders, hepatitis B & C, or HIV, autoimmune disease, systemic lupus, rheumatoid arthritis, glomerulonephritis, sarcoidosis, erythematosus, no Wiskott-Aldrich syndrome, ataxia-telangiectasia, no major medical or psychiatric illness * must be off of steroids for 28 days before treatment * cannot have received interleukin 2, interferon Alfa or other melanoma vaccines * no other invasive cancers diagnosed within the past 3 years * no brain metastases or recurrence by CT scan * No allergy or hypersensitivity to GM-CSF, pentastarch, hetastarch, corn, DMSO, fetal bovine serum or trypsin.* must be willing to comply with study schedule.
Patients will be enrolled sequentially to three different cohorts: Cohort A (low dose) and B (higher dose) and will receive the vaccine only. Cohort C will receive the vaccine and low dose Cyclophosphamide. Patients will receive a total of 4 vaccines. The vaccine is given in our cancer outpatient department) once every 28 days for 4 treatment cycles or 4 months. Each vaccine is given by multiple intradermal injections to the upper thigh and upper arm areas. Patients are seen once a month for blood work, physical exam and symptom review. Total therapy will be 6 months. It is recommended that patients continue onto the long-term extension study; to be assessed yearly for 5 years, for rare clinical events and symptom review.
05/19/2013 04:02 AM