Clinical Trial: Vaccine Trial for Clear Cell Sarcoma, Pediatric Renal Cell Carcinoma, Alveolar Soft Part Sarcoma and Children With Stage IV Melanoma
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase I Trial of Vaccination With Autologous, Lethally Irradiated Tumor Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Granulocyte-Macrophage Colony Stimulating Factor in Pediatric
Brief Summary: The purpose of this study is to learn if a vaccine made from the patient's own tumor cells, then genetically modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), will delay or stop the growth of the tumor. It will also look at the vaccine's effects on the immune system and the side effects of giving a vaccine made from a subject's own cancer cells.
Detailed Summary:
The patient will have surgery to remove a portion of the tumor. This tumor is then brought to a special, certified laboratory where it is broken up into single cells and then washed.
Specially trained laboratory technicians then use a method known as adenoviral mediated gene transfer, which adds a new gene to the cancer calls. This gene causes the cells to make GM-CSF, a powerful hormone that stimulates the immune system. The cells are then given enough radiation so that they will never grow, but not enough to completely destroy them, developing a vaccine.
The patient is then injected with the vaccine on days 0, 7, 14, 28, and then every two weeks until the supply of vaccine has run out. The amount of vaccine that can be made depends upon the total amount of cells taken from the tumor. The actual injections are like childhood vaccinations that go under the skin or into muscle and a different place will be used for each injection.
It is hoped that the cancer cells that have been made to secrete the hormone GM-CSF will cause the patient's immune system to attack the cancer in other parts of the body.
If the tumor yields enough cells, the patient will also be given an injection of non-transduced irradiated tumor cells. Non-transduced means that the gene for GM-CSF has not been added to these cells as it has for the vaccines. This is done to measure the amount of reaction of the immune system caused by the vaccine. This injection is measuring delayed type hypersensitivity, or DTH.
The patient will be asked to undergo optional skin biopsies of the vaccine and DTH sites to see if an immune reaction is occuring at the injection sites 2 days after vaccine 1 and vaccine 5.
Sponsor: Dana-Farber Cancer Institute
Current Primary Outcome: To determine the safety and feasibility of preparation and administration of vaccine in patients with metastatic or locally advanced clear cell sarcoma (CCS), alveolar soft part sarcoma (ASPS) and translocation associated renal cell carcinoma (RCC) [ Time Frame: Years ]
Original Primary Outcome: To determine the safety and feasibility of preparation and administration of vaccine in patients with metastatic or locally advanced CCS, ASPS and translocation associated RCC.
Current Secondary Outcome: To determine the disease response, immune response, and overall survival rate [ Time Frame: TBD ]
Original Secondary Outcome: To determine the disease response, immune response and overall survival rate.
Information By: Dana-Farber Cancer Institute
Dates:
Date Received: November 23, 2005
Date Started: January 2005
Date Completion: January 2017
Last Updated: November 16, 2016
Last Verified: November 2016
