A Phase I Pilot Trial of a Multi-Antigen Loaded Dendritic Cell Vaccine for the Treatment of Advanced Renal Cell Carcinoma
18 Years
N/A
Both
Kidney Cancer
Trial Information
A Phase I Pilot Trial of a Multi-Antigen Loaded Dendritic Cell Vaccine for the Treatment of Advanced Renal Cell Carcinoma
OBJECTIVES: I. Evaluate the safety of multiantigen loaded dendritic cells (DC) vaccine in
patients with advanced renal cell carcinoma. II. Evaluate the immunologic response to this
regimen in this patient population. III. Evaluate the clinical response to this regimen in
this patient population.
OUTLINE: This is a sequential cohort study. All patients undergo total nephrectomy to
harvest primary tumor for vaccine preparation. Patients without primary tumor undergo
surgical resection of the accessible metastatic site for vaccine preparation. Patients are
assigned to 1 of 4 treatment arms. Arm I: Patients receive vaccination with irradiated
autologous tumor lysate (TuLy) intradermally (ID) on day 0 followed by vaccination with
multiantigen liposome loaded dendritic cells (DC) ID on days 7, 14, and 21. Arm II: Patients
receive vaccinations as in arm I, except DC are pulsed with tumor cells. Arm III: Patients
receive vaccination with irradiated autologous tumor lysate (TuLy) IV on day 0 followed by
vaccination with multiantigen liposome loaded DC IV on days 7, 14, and 21. Arm IV: Patients
receive vaccinations as in arm III, except DC are treated as in arm II. Patients are
followed on days 28, 42, 70, and 112.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Inclusion Criteria:
- Histologically confirmed metastatic renal cell carcinoma Evaluable or bidimensionally
measurable disease with primary renal tumor in place or surgically accessible
metastatic site greater than 2 x 2 cm
- Over 18
- ECOG 0-1
- Hematopoietic:
- Hemoglobin at least 10 g/dL (not transfusion dependent)
- Platelet count at least 75,000/mm3
- WBC greater than 3,000/mm3
- Hepatic: SGOT/SGPT no greater than 5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 5 times ULN
- PT/PTT no greater than 1.5 times ULN
- Bilirubin no greater than 2.5 mg/dL
- Renal: Creatinine no greater than 2.0 g/dL
- Hepatitis B surface antigen negative
- Negative pregnancy test
- Fertile patients must use effective contraception
- At least 4 weeks since prior immunotherapy
- At least 4 weeks since prior chemotherapy
- At least 4 weeks since prior radiotherapy
- At least 14 days since prior acute therapy for infection
Exclusion Criteria:
- uncontrolled CNS metastasis
- ischemic heart disease that precludes surgery
- pulmonary condition that precludes surgery
- other underlying condition or allergy that would preclude study
- acute viral, bacterial, or fungal infection requiring therapy HIV negative
- pregnant or nursing
- other acute medical problems that would preclude study
- concurrent corticosteroids (oral, topical, inhaled)
- prior organ allografts
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Barbara J. Gitlitz, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000067542
NCT ID:
NCT00004880
Start Date:
June 1997
Completion Date:
Related Keywords:
- Kidney Cancer
- stage IV renal cell cancer
- recurrent renal cell cancer
- Carcinoma, Renal Cell
- Kidney Neoplasms
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
