- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00093522
Vaccine Therapy With or Without Fludarabine in Treating Patients With Stage IV Kidney Cancer
A Phase II Pilot Study of Tumor-Loaded Dendritic Cells Alone or Following a Non-Myeloablative Conditioning Regimen in Patients With Metastatic Renal Cell Carcinoma
RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with fludarabine may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying vaccine therapy and fludarabine to see how well they work compared to vaccine therapy alone in treating patients with stage IV kidney cancer.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
Primary
- Compare the safety of vaccination comprising autologous dendritic cells loaded with autologous tumor lysate and keyhole limpet hemocyanin with vs without non-myeloablative fludarabine in patients with stage IV renal cell carcinoma.
- Compare, preliminarily, the efficacy of these regimens in these patients.
- Compare the overall survival of patients treated with these regimens.
Secondary
- Determine whether this vaccine induces tumor-reactive peripheral T-cell responses or delayed-type hypersensitivity in these patients.
OUTLINE: This is a pilot, randomized study. Patients are randomized to 1 of 2 treatment arms.
All patients undergo surgery to remove tumor at metastatic sites to generate autologous tumor lysate. Patients then undergo leukapheresis to obtain peripheral blood mononuclear cells for the generation of dendritic cells (DC). The DC are then exposed to autologous tumor lysate and keyhole limpet hemocyanin (KLH).
- Arm I: Three weeks after leukapheresis, patients receive vaccination comprising DC loaded with autologous tumor lysate and KLH (DC vaccine) intradermally once every 14 days for a total of 4 injections in the absence of disease progression or unacceptable toxicity.
- Arm II: Two weeks after leukapheresis, patients receive fludarabine IV over 15-30 minutes once daily for 3 days. Beginning approximately 5 weeks after leukapheresis, patients also receive DC vaccine as in arm I.
Patients are followed at 1, 3, and 7-9 weeks, at 4, 6, 9, and 12 months, and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 28 patients (14 per treatment arm) will be accrued for this study within 2-3 years.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53215
- Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
-
Milwaukee, Wisconsin, United States, 53215
- Midwest Heart Surgery Institute, Limited
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed renal cell carcinoma
- Stage IV disease
- Received no benefit from standard therapy OR ineligible for standard therapy OR declined standard therapy
At least 1 site of metastatic disease that can be surgically removed AND at least 1 site of metastatic disease than can remain in the patient (indicator lesion) after surgery
- Total volume of the site or sites of disease to be surgically removed must be > 2.0 cm^3
Unidimensionally measurable disease
- At least 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- No brain metastasis
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- More than 6 months
Hematopoietic
- WBC ≥ 3,000/mm^3
- Platelet count ≥ 75,000/mm^3
- Hemoglobin ≥ 10 g/dL
Hepatic
- SGPT and SGOT ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- Hepatitis C antibody negative
- Hepatitis B surface antigen negative
Renal
- Creatinine ≤ 1.5 times ULN
- Creatinine clearance > 40 mL/min
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Immunologic
- Coomb's test negative
- HIV-1 and -2 negative
- No active infection
- No unexplained fever (temperature > 100.5° F or 38.1°C)
- No lymphocytopenia
- No hypogammaglobulinemia
- No autoimmune disease or other immunocompromising condition that would preclude study participation
- No history of impaired immune response
- No history of tuberculosis OR positive PPD skin test
- No history of allergic reaction attributed to compounds of similar biological composition to study vaccine
- No history of allergic reaction to antibiotics
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 month after study participation
- No psychiatric illness or social situation that would preclude study participation
- No other malignancy within the past 5 years except resected basal cell carcinoma or carcinoma in situ of the cervix
- No other concurrent illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 4 weeks since prior immunotherapy
Chemotherapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
Endocrine therapy
- At least 4 weeks since prior steroid therapy or steroid-containing compounds
- At least 2 weeks since prior topical or inhaled steroids
Radiotherapy
- More than 4 weeks since prior radiotherapy
Surgery
- See Disease Characteristics
Other
- More than 4 weeks since prior investigational agents
- More than 1 week since prior antibiotics
- No concurrent renal dialysis
- No concurrent anticoagulants
- No other concurrent anticancer agents or therapies
- No other concurrent investigational agents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Safety as measured by NCI common toxicity table at completion of study
|
Response as measured by RECIST guidelines and the Kaplan-Meier method at 5 years
|
Survival as measured by the Kaplan-Meier method at 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John P. Hanson, MD, St. Luke's Medical Center
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
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
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Fludarabine
- Fludarabine phosphate
- Keyhole-limpet hemocyanin
Other Study ID Numbers
- CDR0000389145
- STLMC-IMM-03-05
- STLMC-L-03-138
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.
Clinical Trials on Kidney Cancer
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnKidney/Urinary Cancer
-
PfizerCompletedKidney Cancer | Kidney Neoplasms | Renal Cell Carcinoma | Renal Cancer | Renal Cell Cancer | Cancer of the Kidney | Cancer of KidneyFinland
-
Tianjin Medical University Second HospitalRecruiting
-
Tianjin Medical University Second HospitalRecruiting
-
Cedars-Sinai Medical CenterRecruitingProstate Cancer Stage II | Prostate Cancer Stage I | Bladder Cancer Stage II | Kidney Cancer Stage IUnited States
-
Dana-Farber Cancer InstituteCompletedKidney Cancer | Prostate Cancer | Genitourinary CancerUnited States
-
Intuitive SurgicalCompleted
-
University of Texas Southwestern Medical CenterCompletedKidney Cancer | Kidney Cancer Metastatic | Kidney Cancer, Stage IVUnited States
-
Yale UniversityCompleted
-
Stanford UniversityNational Cancer Institute (NCI)WithdrawnProstate Cancer | Bladder Cancer | Kidney Tumor
Clinical Trials on fludarabine phosphate
-
NCIC Clinical Trials GroupCompleted
-
Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI)CompletedMyelodysplastic Syndromes | Leukemia | Myelodysplastic/Myeloproliferative DiseasesUnited States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)UnknownGraft Versus Host Disease
-
Genzyme, a Sanofi CompanyCompleted
-
M.D. Anderson Cancer CenterVion PharmaceuticalsCompletedHematologic MalignanciesUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedMelanoma (Skin)United States
-
Genzyme, a Sanofi CompanyCompleted
-
Genzyme, a Sanofi CompanyCompleted
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedHead and Neck CancerUnited States
-
St. Petersburg State Pavlov Medical UniversityRecruitingMultiple SclerosisRussian Federation