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Phase 1/2 Study to Assess the Safety and Efficacy of Vaccinations With Allogeneic Dendritic Cells: Autologous Tumor-Derived Cells Subjected to Electrofusion in Patients With AJCC Stage IV Renal Cell Carcinoma

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

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Trial Information

Phase 1/2 Study to Assess the Safety and Efficacy of Vaccinations With Allogeneic Dendritic Cells: Autologous Tumor-Derived Cells Subjected to Electrofusion in Patients With AJCC Stage IV Renal Cell Carcinoma

Approximately 30,000 new cases of kidney cancer will be diagnosed in the U.S. in 2002, with
renal cell carcinoma (RCC) being the most commonly diagnosed type. For patients with
locally advanced or metastatic disease, the treatment options are extremely limited and
additional options are warranted. Although RCC is generally considered resistant to
chemotherapy, spontaneous regressions in patients with metastatic disease have led to
research involving immune-mediated therapeutic approaches. Clinical responses have been
observed and additional immune-modulating therapeutics are being studied.

Several such approaches have used dendritic cells (DCs), which are known to be potent
antigen presenting cells. An antigen is a protein that, when shown to the immune system in
the right way, can trigger the cells of the immune system to recognize, remember and
eliminate other cells that also display that specific antigen. The cancerous cells in
tumors present antigens in such a way that the body's immune system often fails to recognize
and eliminate them. It is theorized that when DCs are fused to tumor cells the resulting
fused cells will be capable of presenting tumor antigens in an enhanced manner, thus
allowing the body's immune system to recognize the tumor antigens on the cancer itself. If
this occurs, the patient's immune system may be specifically stimulated, producing a
clinically meaningful immune response against the tumor.

In this study DCs produced from healthy volunteer donors (allogeneic DCs) will be fused to
the patient's own tumor cells (autologous tumor cells), using an electrical current. The
fused dendritic/tumor cells will be returned to the patient in a series of vaccines, six
weeks apart.

The purpose of this trial is to determine whether fusing autologous tumor with allogeneic
DCs will, with limited associated toxicity, present tumor antigen in such a way as to
stimulate an immune response and also show evidence of tumor response.

Inclusion Criteria:

- The patient must be greater than or equal to 18 years of age.

- The patient must be diagnosed with AJCC Stage IV (primary or relapsed) Renal Cell

- The patient must have a Screening Eastern Cooperative Oncology Group (ECOG) Clinical
Performance Status of 0-1.

- The patient must have accessible tumor (minimum of 2.5 cm in diameter in aggregate
and accessible as defined in the clinical protocol) for vaccine production.

- The patient must have measurable tumor lesions (using Response Evaluation Criteria in
Solid Tumors [RECIST]) following resection of tumor lesion(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 at
Screening: White blood cell (WBC) count greater than or equal to 3,000 cells/mm3;
Platelet count greater than or equal to 100,000 platelets /mm3; Creatinine (serum)
less than 2.0 mg/dL; Total bilirubin less than 2.0 mg/dL; Serum glutamic pyruvate
transaminase (SGPT)/alanine aminotransferase (ALT) less than 2.0 x Upper limits of
normal; Serum glutamic oxaloacetic transaminase (SGOT)/ aspartate aminotransferase
(AST) less than 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 to 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 for the treatment of RCC.

- The patient has received more than 2 prior regimens 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 screening

- The patient has a clinically significant autoimmune disorder.

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

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

- The patient has a history of more than one brain metastasis. Patients with a history
of a single brain metastasis must have completed definitive treatment for this
metastasis not less than 12 weeks prior to the time of first screening procedure and
have remained clinically stable during this interval.

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

- The patient is receiving chronic immunosuppressive and/or oral steroid 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:

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


United States: Food and Drug Administration

Study ID:




Start Date:

November 2002

Completion Date:

Related Keywords:

  • Carcinoma, Renal Cell
  • Stage IV Renal Cell Carcinoma
  • Kidney Cancer
  • Cancer (General)
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
UCLA Medical Center Los Angeles, California  90095-7059
The Cleveland Clinic Foundation Cleveland, Ohio  
Dana Farber Cancer Institute (DFCI) Boston, Massachusetts  02215