- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00014131
Vaccine Therapy in Treating Patients With Kidney Cancer
Vaccine Biotherapy Of Cancer: Autologous Tumor Cells And Dendritic Cells As Active Specific Immunotherapy In Patients With Stage IV Renal Cell Carcinoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the safety of immunization with in vitro-treated autologous tumor cells and dendritic cells with sargramostim (GM-CSF) in patients with stage III or IV or recurrent renal cell cancer.
- Determine the frequency of conversion of delayed tumor hypersensitivity tests in these patients treated with this regimen.
- Determine the progression-free and overall survival of these patients treated with this regimen.
- Determine the objective tumor response rate in patients who still have measurable disease at the time they are treated with this regimen.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
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Newport Beach, California, United States, 92663
- Hoag Cancer Center at Hoag Memorial Hospital Presbyterian
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
DISEASE CHARACTERISTICS:
Histologically confirmed renal cell carcinoma
- Stage III or IV disease involving invasions beyond Gerota's fascia, regional lymph node involvement, or distant metastases OR
- Recurrent disease involving lymph node metastases or soft tissue nodules
- Measurable disease by anatomic-based radiological tests (unless no evidence of disease as documented by prior surgery)
- Planned resection of tumor to establish an autologous tumor cell line
No active CNS metastases such as brain metastases, spinal cord compression, or leptomeningeal disease
- Prior brain metastases or spinal cord compression allowed provided there is radiographic evidence of lack of progression and no requirement for pharmacologic doses of corticosteroids
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 4 months
Hematopoietic:
- Hematocrit greater than 25%
- Platelet count greater than 100,000/mm3
- No ongoing transfusion requirements
- No active blood clotting or bleeding diathesis
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- Albumin at least 3.0 g/dL
- No significant hepatic dysfunction
Renal:
- Creatinine no greater than 2.0 mg/dL
- No significant renal dysfunction
Cardiovascular:
- No underlying cardiac disease associated with New York Heart Association class III or IV heart function
- No unstable angina related to atherosclerotic cardiovascular disease
Other:
- No other malignancy within the past 5 years except carcinoma in situ, basal cell or localized squamous cell skin cancer, or localized prostate cancer
- No active infection
- No other active medical condition that could be eminently life threatening
- Not pregnant
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Other prior putative vaccines allowed
- Recovered from prior biologic therapy
- No concurrent biologic therapy except epoetin alfa for patients with hematocrit less than 36%
Chemotherapy:
- At least 3 weeks since prior chemotherapy and recovered
- No concurrent chemotherapy
Endocrine therapy:
- See Disease Characteristics
- No concurrent corticosteroids
Radiotherapy:
- At least 3 weeks since prior radiotherapy (including whole-brain radiotherapy) and recovered
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- Recovered from prior surgery
Other:
- Concurrent bisphosphonates allowed for patients with lytic bone metastases
- No concurrent digoxin or other medications designed to improve cardiac output
- No other concurrent anticancer therapy or investigational therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Biological/Vaccine
Biological/Vaccine: therapeutic autologous dendritic cells.
Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product.
|
Biological/Vaccine: therapeutic autologous dendritic cells.
Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Conversion of the delayed-type hypersensitivity (DTH) skin test as measured by metric skin ruler at week 4 and month 6 during vaccine therapy
Time Frame: week 4 and month 6 during vaccine therapy
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week 4 and month 6 during vaccine therapy
|
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
Time Frame: months 2 or 3 and 6 during study treatment, and 6 months after study completion
|
months 2 or 3 and 6 during study treatment, and 6 months after study completion
|
Progression-free survival as measured by RECIST at months 2 or 3 and 6 during study treatment and every 6 months after study completion
Time Frame: months 2 or 3 and 6 during study treatment and every 6 months after study completion
|
months 2 or 3 and 6 during study treatment and every 6 months after study completion
|
Event-free survival as measured by RECIST at months 2 or 3 and 6 during study treatment and every 6 months after study completion
Time Frame: months 2 or 3 and 6 during study treatment and every 6 months after study completion
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months 2 or 3 and 6 during study treatment and every 6 months after study completion
|
Overall survival beginning at the date of study entry
Time Frame: 5 years or until death, whichever came first.
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5 years or until death, whichever came first.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Robert O. Dillman, MD, FACP, Hoag Memorial Hospital Presbyterian
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Neoplasms
- Carcinoma, Renal Cell
Other Study ID Numbers
- CDR0000068493
- HOAG-VACCINE-RN (Other Identifier: Hoag Cancer Center at Hoag Memorial Hospital Presbyterian)
- NCI-V01-1647 (Other Identifier: National Cancer Institute)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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