Vaccination of Patients With Renal Cell Cancer With Dendritic Cell Tumor Fusions and GM-CSF - Full Text View

Sponsor:	Beth Israel Deaconess Medical Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00458536

Purpose

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.

Condition	Intervention	Phase
Renal Cancer	Biological: Dendritic Cell Tumor Fusion Vaccine Drug: Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Vaccination of Patients With Renal Cell Cancer With Dendritic Cell Tumor Fusions and GM-CSF

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To assess the toxicity associated with and to investigate the clinical impact of vaccination with mature DC/Tumor fusion and GM-CSF of this patient population. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine if cellular and humoral immunity is induced by serial vaccination with DC/tumor fusion cells and GM-CSF [ Time Frame: 5 years ] [ Designated as safety issue: No ]
to correlate immunologic response following vaccination. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	51
Study Start Date:	October 2004
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Intervention Details:

3 vaccinations at three week intervals

Combined with the vaccine in the remaining subjects after the first 6 are enrolled.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458536

Contacts

Contact: David Avigan, MD

617-667-9920

davigan@bidmc.harvard.edu

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Contact: David Avigan, MD 617-667-9920 davigan@bidmc.harvard.edu
Contact: Dilani Dombagoda 617-667-5984 ddombago@bidmc.harvard.edu
Sub-Investigator: Jacalyn Rosenblatt, MD
Sub-Investigator: James D Levine, MD
Sub-Investigator: Robin Joyce, MD
Sub-Investigator: Lynne Uhl, MD
Sub-Investigator: David McDermott, MD
Sub-Investigator: Michael Atkins, MD
Sub-Investigator: James Mier, MD
Sub-Investigator: Donald Kufe, MD
Sub-Investigator: Daniel Cho, MD
Sub-Investigator: Corrine Lenahan, MD

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

David Avigan, MD

Beth Israel Deaconess Medical Center

More Information

No publications provided

Responsible Party:	Beth Israel Deaconess Medical Center ( David Avigan, MD )
Study ID Numbers:	04-117
Study First Received:	April 10, 2007
Last Updated:	September 29, 2009
ClinicalTrials.gov Identifier:	NCT00458536 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

GM-CSF
vaccine
debulking nephrectomy
dendritic cells

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell

Urogenital Neoplasms
Kidney Diseases
Urologic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 27, 2009