Vaccination of Patients With Renal Cell Cancer With Dendritic Cell Tumor Fusions and GM-CSF
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/27/2018 |
| Start Date: | October 2004 |
| End Date: | December 2019 |
The main purpose of this study is to test the safety of the dendritic cell/tumor fusion study
vaccine in combination with a laboratory-made agent called Granulocyte Macrophage Colony
Stimulating Factor (GM-CSF). Another purpose is to determine the type and severity of any
side effects associated with this study vaccine. GM-CSF is similar to a substance in the body
that stimulates the production of white blood cells. To create the study vaccine, cells will
be removed from the participants tumor and fused with dendritic cells which are obtained from
the participants blood. Dendritic cells are responsible for immune responses to "foreign"
substances that enter the body. Animal studies have shown that these fused cells can
stimulate powerful anti-tumor responses.
vaccine in combination with a laboratory-made agent called Granulocyte Macrophage Colony
Stimulating Factor (GM-CSF). Another purpose is to determine the type and severity of any
side effects associated with this study vaccine. GM-CSF is similar to a substance in the body
that stimulates the production of white blood cells. To create the study vaccine, cells will
be removed from the participants tumor and fused with dendritic cells which are obtained from
the participants blood. Dendritic cells are responsible for immune responses to "foreign"
substances that enter the body. Animal studies have shown that these fused cells can
stimulate powerful anti-tumor responses.
- Patients are being asked to participate if they have chosen to undergo a "debulking
nephrectomy" (surgery to remove a tumor of the kidney, but not all of the cancer cells
in their body) as a standard treatment for kidney cancer or they have tumor lesions that
are accessible and are being removed to treat or diagnose their cancer.
- Participants enrolled in this study will be assigned to receive a particular dose of the
dendritic cell/tumor fusion vaccine cells. The dose will be determined by when they are
enrolled in the study. There are two cohorts to this study. The first cohort will be
given the vaccine alone. If the vaccine is well tolerated then we will proceed to the
second cohort. The second cohort will receive GM-CSF in addition to the vaccine.
- Tumor cells will be collected to make the study vaccine. Based on the location of the
cancer, a decision will be made as to the best approach to obtain these cells.
- Participants will undergo a procedure known as leukapheresis in order to obtain their
dendritic cells. Prior to this procedure they will receive 1 to 2 injection of GM-CSF to
help increase their white blood cell count.
- If sufficient numbers of cells are obtained, tumor cells and dendritic cells will be
fused (mixed) together in the laboratory and divided into the appropriate doses for
administration.
- The treatment will consist of 3 vaccinations of fused cells given by an injection under
your skin at 3-week intervals. The first six participants will receive only the study
vaccine. The remaining participants will receive the study vaccine combined with GM-CSF.
- If enough vaccine cannot be made for the participant to receive 3 doses, the participant
may receive only 2 doses of the study vaccine.
- Approximately 3 to 4 tablespoons of blood will be collected at certain times for testing
the immune system and to determine if the study vaccine has increased the immune
response against the tumor cells. Weekly visits for physical exam, assessment of adverse
events and safety labs will be conducted.
- Regular blood draws will be done for at least 6 months following the completion of the
study to follow safety labs and to monitor the immune response. Monthly physical exams
will be performed following the last injection of the study vaccine. At one month, three
months, and six months following the date the participant received the last study
vaccine, they will have a CT scan to see if the study vaccine has affected their
disease.
nephrectomy" (surgery to remove a tumor of the kidney, but not all of the cancer cells
in their body) as a standard treatment for kidney cancer or they have tumor lesions that
are accessible and are being removed to treat or diagnose their cancer.
- Participants enrolled in this study will be assigned to receive a particular dose of the
dendritic cell/tumor fusion vaccine cells. The dose will be determined by when they are
enrolled in the study. There are two cohorts to this study. The first cohort will be
given the vaccine alone. If the vaccine is well tolerated then we will proceed to the
second cohort. The second cohort will receive GM-CSF in addition to the vaccine.
- Tumor cells will be collected to make the study vaccine. Based on the location of the
cancer, a decision will be made as to the best approach to obtain these cells.
- Participants will undergo a procedure known as leukapheresis in order to obtain their
dendritic cells. Prior to this procedure they will receive 1 to 2 injection of GM-CSF to
help increase their white blood cell count.
- If sufficient numbers of cells are obtained, tumor cells and dendritic cells will be
fused (mixed) together in the laboratory and divided into the appropriate doses for
administration.
- The treatment will consist of 3 vaccinations of fused cells given by an injection under
your skin at 3-week intervals. The first six participants will receive only the study
vaccine. The remaining participants will receive the study vaccine combined with GM-CSF.
- If enough vaccine cannot be made for the participant to receive 3 doses, the participant
may receive only 2 doses of the study vaccine.
- Approximately 3 to 4 tablespoons of blood will be collected at certain times for testing
the immune system and to determine if the study vaccine has increased the immune
response against the tumor cells. Weekly visits for physical exam, assessment of adverse
events and safety labs will be conducted.
- Regular blood draws will be done for at least 6 months following the completion of the
study to follow safety labs and to monitor the immune response. Monthly physical exams
will be performed following the last injection of the study vaccine. At one month, three
months, and six months following the date the participant received the last study
vaccine, they will have a CT scan to see if the study vaccine has affected their
disease.
Inclusion Criteria:
- Patients with stage IV renal cancer who have not received prior chemotherapy or
biological therapy
- Patients who are to undergo debulking nephrectomy for independent clinical indications
or patients with other sites of accessible disease
- Tumor tissue should be at least 2.0cm in longest dimension
- Patients should meet prognostic criteria for intermediate or favorable risk disease as
defined by Motzer criteria
- Measurable metastatic disease as defined by a lesion of at least 1cm outside the
lesion used for vaccine generation and exclusive of bony metastases
- ECOG Performance Status of 0-2 with greater than six week life expectancy
- 18 years of age or older
- Lab results within range outlined in protocol
Exclusion Criteria:
- Patients who have received prior chemotherapy
- Clinical evidence of CNS disease. Patients with a history of treated brain metastasis
must be stable with no evidence of disease for 3 months
- HIV positive
- Serious intercurrent illness such as infection requiring IV antibiotics, or
significant cardiac disease characterized by significant arrhythmia, unstable ischemic
coronary disease or congestive heart failure
- Pregnant of lactating women
- History of clinically significant venous thromboembolism
We found this trial at
1
site
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
Click here to add this to my saved trials
