Vaccine Trial for Clear Cell Sarcoma, Pediatric Renal Cell Carcinoma, Alveolar Soft Part Sarcoma and Children With Stage IV Melanoma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Skin Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/24/2019 |
| Start Date: | January 2005 |
| End Date: | June 2019 |
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
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.
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.
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.
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 patient's 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 patient's 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 patient's disease worsens; the
patient experiences an unacceptable and/or harmful side effect; the patient becomes pregnant;
the patient is unable to follow the study plan; or the patient's doctor feels it is no longer
in the best interest of the patient to continue.
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.
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 patient's 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 patient's 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 patient's disease worsens; the
patient experiences an unacceptable and/or harmful side effect; the patient becomes pregnant;
the patient is unable to follow the study plan; or the patient's doctor feels it is no longer
in the best interest of the patient to continue.
Inclusion Criteria:
- ECOG performance status 0 or 1
- Estimated life expectancy of greater than 6 months
- Greater than or equal to 4 weeks from chemotherapy, radiotherapy, immunotherapy, or
systemic glucocorticoid therapy
- Greater than or equal to 6 months from prior bone marrow or peripheral blood stem cell
(PBSC) transplant
- Histologically confirmed alveolar soft part sarcoma or clear cell sarcoma at any age.
- Evidence of metastatic disease, including having spread either to distant sites that
may include brain metastases, or to regional lymph nodes alone, or locally advanced
primary lesion that is not fully surgically resectable at study entry.
- Histologically confirmed Stage IV renal cell carcinoma (patients with brain metastases
still eligible)
- Any patients with Stage IV renal cell carcinoma under the age of 25 years who do not
have a renal cell carcinoma predisposition syndrome
- Patients with Stage IV melanoma and under the age of 18 years
Exclusion Criteria:
- Uncontrolled active infection
- Pregnancy or nursing mothers
- Infection with HIV, hepatitis B or hepatitis C
- Any other significant medical, surgical, or psychiatric condition that may interfere
with compliance with protocol regimen
- Other current malignancies apart from any in situ cancer or basal or squamous cell
carcinoma
- Pediatric melanoma only: infants with transplacentally acquired melanoma; or children
with brain metastases and malignant melanoma.
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