Status:
COMPLETED
Vaccination With Autologous, Lethally Irradiated Melanoma Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Granulocyte-Macrophage Stimulating Factor (GMSF)
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Massachusetts General Hospital
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to see if the proposed therapy will delay or stop the progression of the participants skin cancer. This study is being done because there are currently no treatments which...
Detailed Description
* The vaccines created from the participants melanoma cells are scheduled to be given to the participants on days 1, 8, 15, 29 and every two weeks after until the supply of vaccine has run out. The am...
Eligibility Criteria
Inclusion
- Stage III patients must have: A) Histologically documented melanoma B) Lymphadenopathy of at least 2cm in greatest diameter by physical exam or CT scan in a region draining a known or suspected primary melanoma or in transit metastatic disease of at least 2cm in greatest diameter by physical exam or CT in a region draining a known primary melanoma C) refused, not eligible, or failed adjuvant therapy with high dose a-interferon D) must be able to have all measurable disease removed at time of tumor harvest
- Stage IV patients must have histologically documented metastatic melanoma
- ECOG Performance Status 0 or 1
- Estimated life expectancy of 6 months or greater
- 18 years of age or older
- Signed Informed Consent
- Greater than 4 weeks from any chemotherapy, radiotherapy, immunotherapy, or systemic glucocorticoid therapy
- Greater than 6 months since bone marrow or peripheral blood stem cell transplant
Exclusion
- Uncontrolled active infection
- Pregnancy or nursing mothers
- Evidence of infection with Human Immunodeficiency Virus, Hepatitis B or C
Key Trial Info
Start Date :
October 16 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2020
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00809588
Start Date
October 16 2003
End Date
February 25 2020
Last Update
August 21 2024
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115