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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Renal Cancer

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Trial Information

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

- 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

- 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

- 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

- 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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

David Avigan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

October 2004

Completion Date:

December 2013

Related Keywords:

  • Renal Cancer
  • GM-CSF
  • vaccine
  • debulking nephrectomy
  • dendritic cells
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215