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A Phase I/II Study to Assess the Safety and Efficacy of Vaccinations With Allogeneic Dendritic Cells: Autologous Tumor-Derived Cells Subjected to Electrofusions in Patients With AJCC Stage IV Renal Cell Carcinoma

Phase 1/Phase 2
18 Years
Not Enrolling
Renal Cell Carcinoma

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Trial Information

A Phase I/II Study to Assess the Safety and Efficacy of Vaccinations With Allogeneic Dendritic Cells: Autologous Tumor-Derived Cells Subjected to Electrofusions in Patients With AJCC Stage IV Renal Cell Carcinoma

Patients undergo tumor aquisition and short-term tumor cell cultures are established.
Leukopheresis is performed monocyte-derived DC are generated ex-vivo by standard culture
techniques, utilizing GM-CSF and Il-4. PEG fusions are generated, and following irradiation,
the vaccine is frozen. The thawed vaccine is administered SC into a single site every three
weeks. Each study is examining a dose-escalating strategy based apon the number PEG-fused
generated from the PEG process that expressed both tumor cell and DC markers as determined
by immune staining.

Inclusion Criteria:

- The patient must be _> 18 years of age

- The patient must be diagnosed with AJCC stage IV (primary or relasped) RCC

- The patient must have a baseline Eastern Cooperative Oncology Group (ECOG) Clinical
performance of 0-1

- The patient must have accessible tumor (minimum of 2.5cm in diameter in aggregate and
accessible) for vaccine production

- The patient must have measurable tumor lesions (using Response Evaluation Criteria in
Solid Tumors (RECIST) following resection of tumor lesions(s) used for vaccine
production. If the patient has received previous radiation or intra-tumoral
investigational treatments, the measurable disease must be outside the previous
radiation port or treatment area unless there is documented tumor progression
following the completion of therapy.

- The patient must have adequate hematologic, hepatic, and renal function parameters
within 21 days prior to the first vaccination (day 0 of treatment):

- White blood cell(WBC) count >_ 3,000 cell/mm3

- Platelet count >_ 100,000 platelets/mm3

- Creatine(serum) <2.0mg/dL

- Total bilirubin <2.0 mg/dL

- Serum glutamic pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) <2.0
x Upper limits of normal

- Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST)
< 2.0 x Upper limits of normal

- The patient must be serologically negative for human immunodeficiency virus (HIV)-1,
HIV-2, and human T lymphotropic virus (HTLV)-1

- Female patients of childbearing potential must have negative pregnancy tests, refrain
from nursing and must agree ton use appropriate contraception for the duration of the

- The patient must have signed and dated written informed consent prior to any study
procedures. The consent process must be documented in the patient's medical record

Exclusion Criteria:

- The patient has received prior chemotherapy

- The patient's tumor-derived cells do not meet predetermined manufacturing
specifications, for example: human leukocyte antigen (HLA) Class 1 molecule
expression, sufficient tumor derived cells for vaccine manufacture, or pathologic
confirmation of RCC

- The patient has received more than 2 prior regimes for treatment of RCC and the most
recent is within 2 weeks of the first screening procedure

- The patient has received radiation therapy within 2 weeks of the first sceeening

- The patient has a clinically significant autoimmune diorder

- The patient has an active infection at the time of the first screening procedure
requiring parenteral antibiotics

- The patient has clinically significant hematolgic, cardiac, renal, or hepatic disease
or any other underlying condition that would contraindicate study therapy or confuse
interpretation of study results

- The patient has any active or clinically significant central nervous system (CNS)

- The patient has a previous unrelated malignancy or second malignancy within 5 years
prior to the first screening procedure, except from non-melanoma skin cancer and in
situ carcinomas

- The patient is receiving chronic immunosuppressive, and/or oral steriod treatment

- The patient has any other reason in the Investigator's opinion that would make
protocol compliance unmanageable or may compromise the patient's ability to give
informed consent

- The patient has been treated with a non-oncologic investigational drug, biologic or
medical device within 30 days of the first screening procedure

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the safety of 3 serial vaccinations with allogeneic DCs: autologous tumor-derived cells subjected to electrofusion in patients with AJCC stage IV RCC

Outcome Time Frame:

screening/baseline, treatment period, follow-up and long-term follow-up

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:

December 2002

Completion Date:

February 2008

Related Keywords:

  • Renal Cell Carcinoma
  • renal cell carcinoma
  • AJCC Stage IV (primary or relasped) renal cell carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell



BIDMC Boston, Massachusetts  02215