Vaccination With Autologous, Lethally Irradiated Melanoma Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Granulocyte-Macrophage Stimulating Factor (GMSF)
- Conditions
- Melanoma
- Registration Number
- NCT00809588
- Lead Sponsor
- Dana-Farber Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Stage III patients must have: A) Histologically documented melanoma B)<br> Lymphadenopathy of at least 2cm in greatest diameter by physical exam or CT scan in<br> a region draining a known or suspected primary melanoma or in transit metastatic<br> disease of at least 2cm in greatest diameter by physical exam or CT in a region<br> draining a known primary melanoma C) refused, not eligible, or failed adjuvant<br> therapy with high dose a-interferon D) must be able to have all measurable disease<br> removed at time of tumor harvest<br><br> - Stage IV patients must have histologically documented metastatic melanoma<br><br> - ECOG Performance Status 0 or 1<br><br> - Estimated life expectancy of 6 months or greater<br><br> - 18 years of age or older<br><br> - Signed Informed Consent<br><br> - Greater than 4 weeks from any chemotherapy, radiotherapy, immunotherapy, or systemic<br> glucocorticoid therapy<br><br> - Greater than 6 months since bone marrow or peripheral blood stem cell transplant<br><br>Exclusion Criteria:<br><br> - Uncontrolled active infection<br><br> - Pregnancy or nursing mothers<br><br> - Evidence of infection with Human Immunodeficiency Virus, Hepatitis B or C
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the doses of lethally irradiated, autologous melanoma cells engineered by adenoviral mediated gene transfer to secrete CM-CSF that can be manufactured in stage III melanoma patients.
- Secondary Outcome Measures
Name Time Method To determine the safety and biologic activity of vaccination with lethally irradiated, autologous melanoma cells engineered by adenoviral mediated gene transfer to secrete GM-CSF;To determine the two-year survival of stage IV melanoma patients vaccinated with lethally irradiated, autologous melanoma cells engineered by adenoviral mediated gene transfer to secrete GM-CSF;To determine more fully the safety and biologic activity of vaccination with lethally irradiated, autologous melanoma cells engineered by adenoviral mediated gene transfer to secrete GM-CSF in stage IV melanoma patients