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| Descriptive Information Fields | |||||
| Brief Title † | Vaccine Therapy in Treating Patients With Kidney Cancer | ||||
| Official Title † | Vaccine Biotherapy Of Cancer: Autologous Tumor Cells And Dendritic Cells As Active Specific Immunotherapy In Patients With Stage IV Renal Cell Carcinoma | ||||
| Brief Summary | RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent or stage III or stage IV kidney cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Patients are stratified according to measurable disease at the time vaccine therapy is initiated (yes vs no). Patients undergo tumor cell harvest. Patients with multiple persistent sites of metastatic disease following harvest receive systemic therapy (biologic therapy and/or chemotherapy) during tumor cell line expansion. Over 2-4 months, the tumor cell line is expanded, treated with interferon gamma, and irradiated. Patients undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMC). The PBMC are incubated over 7 days with sargramostim (GM-CSF) and interleukin-4 to produce dendritic cells (DC). The DC are incubated over 2-3 days with the irradiated tumor cells from the autologous tumor cell line for antigen loading of the DC. Patients undergo delayed tumor hypersensitivity testing 1 week prior to vaccination and again at week 4. Patients receive vaccine therapy comprising autologous treated tumor cells and DC suspended in GM-CSF subcutaneously weekly for 3 weeks. Vaccine therapy continues monthly for 5 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year and then every 3 months for 4 years. PROJECTED ACCRUAL: A total of 80 patients (40 per stratum) will be accrued for this study. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment | ||||
| Primary Outcome Measure † | Conversion of the delayed-type hypersensitivity (DTH) skin test as measured by metric skin ruler at week 4 and month 6 during vaccine therapy [ Designated as safety issue: No ] Tumor response (partial response or complete response) as measured by RECIST at months 2 or 3 and 6 during study treatment, and 6 months after study completion [ Designated as safety issue: No ] Progression-free survival as measured by RECIST at months 2 or 3 and 6 during study treatment and every 6 months after study completion [ Designated as safety issue: No ] Event-free survival as measured by RECIST at months 2 or 3 and 6 during study treatment and every 6 months after study completion [ Designated as safety issue: No ] Overall survival beginning at the date of study entry [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | |||||
| Condition † | Kidney Cancer | ||||
| Intervention † | Drug: autologous tumor cell vaccine Drug: sargramostim Drug: therapeutic autologous dendritic cells |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 80 | ||||
| Start Date † | November 2001 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | 16 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00014131 | ||||
| Organization ID | CDR0000068493 | ||||
| Secondary IDs †† | HOAG-VACCINE-RN, NCI-V01-1647 | ||||
| Study Sponsor † | Hoag Memorial Hospital Presbyterian | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | March 2008 | ||||
| First Received Date † | April 10, 2001 | ||||
| Last Updated Date | July 23, 2008 | ||||