Status:
UNKNOWN
Vaccine Therapy With or Without Fludarabine in Treating Patients With Stage IV Kidney Cancer
Lead Sponsor:
St. Luke's Medical Center
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 diff...
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 flud...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00093522
Start Date
August 1 2004
Last Update
December 19 2013
Active Locations (2)
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1
Midwest Heart Surgery Institute, Limited
Milwaukee, Wisconsin, United States, 53215
2
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215