Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258687
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2005-11-23
Brief Title:
Vaccine Trial for Clear Cell Sarcoma Pediatric Renal Cell Carcinoma Alveolar Soft Part Sarcoma and Children With Stage IV Melanoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
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 and Adult Patients
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to learn if a vaccine made from the patients 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 vaccines effects on the immune system and the side effects of giving a vaccine made from a subjects own cancer cells
Detailed Description:
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 patients 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
The following tests and procedures will be performed through out the study physical exam blood samples immune studies vital signs and physical exam
At week 10 in the patients treatment or earlier if the doctor feels it is necessary the patient will undergo a chest abdomen and pelvic XT scan A brain MRI will be performed if there were any abnormalities on the first brain MRI or if any new central nervous system symptoms have developed
If the patients disease has not disappeared or if new lesions have been found after the patient receives at least six vaccines they may have the opportunity to undergo a second course of study treatment
Patients may participate in this study until one of the following happens All vaccine created from the tumor has been given to the patient the patients disease worsens the patient experiences an unacceptable andor harmful side effect the patient becomes pregnant the patient is unable to follow the study plan or the patients doctor feels it is no longer in the best interest of the patient to continue
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 patients 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
The following tests and procedures will be performed through out the study physical exam blood samples immune studies vital signs and physical exam
At week 10 in the patients treatment or earlier if the doctor feels it is necessary the patient will undergo a chest abdomen and pelvic XT scan A brain MRI will be performed if there were any abnormalities on the first brain MRI or if any new central nervous system symptoms have developed
If the patients disease has not disappeared or if new lesions have been found after the patient receives at least six vaccines they may have the opportunity to undergo a second course of study treatment
Patients may participate in this study until one of the following happens All vaccine created from the tumor has been given to the patient the patients disease worsens the patient experiences an unacceptable andor harmful side effect the patient becomes pregnant the patient is unable to follow the study plan or the patients doctor feels it is no longer in the best interest of the patient to continue
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None