Status:
COMPLETED
Vaccine Therapy in Treating Patients With Kidney Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Vaccines made from DNA may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase I trial is studying the side effects and best dose of vaccine therapy ...
Detailed Description
OBJECTIVES: Primary * Determine the safety and feasibility of vaccination with human and mouse prostate-specific membrane antigen (PSMA) DNA in patients with renal cell carcinoma. * Determine the ma...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed renal cell carcinoma
- Patients with minimal disease burden are eligible provided they meet one or more of the following criteria:
- Prior nephrectomy and completely resected metastases
- Favorable-risk group, as defined by all of the following criteria:
- Karnofsky 80-100%
- Hemoglobin ≥ 13 g/dL (male) or ≥ 12 g/dL (female)
- Corrected calcium ≤ 10 mg/dL
- Prior nephrectomy
- Serum lactate dehydrogenase ≤ 200 μ/L
- Prior nephrectomy with metastases confined to lung and/or small volume metastatic disease (\< 3 cm) exclusive of bone and liver
- No spinal, epidural, or CNS lesions
- No bone, liver or brain disease
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- See Disease Characteristics
- Karnofsky 80-100%
- Life expectancy
- Not specified
- Hematopoietic
- See Disease Characteristics
- WBC ≥ 3,500/mm\^3
- Hemoglobin ≥ 12.0 g/dL
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Bilirubin \< 2.0 mg/dL
- SGOT \< 3.0 times upper limit of normal
- Renal
- See Disease Characteristics
- Creatinine ≤ 2.0 mg/dL OR
- Creatinine clearance ≥ 40 mL/min
- Cardiovascular
- No clinically significant cardiac disease
- No New York Heart Association class III or IV heart disease
- Pulmonary
- No severe debilitating pulmonary disease
- Other
- Fertile patients must use effective contraception
- No other active secondary malignancy within the past 5 years except non-melanoma skin cancer
- No infection requiring antibiotic treatment
- No narcotic- or steroid-dependent pain
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- At least 4 weeks since prior chemotherapy
- Endocrine therapy
- At least 4 weeks since prior corticosteroid therapy
- Radiotherapy
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy to only measurable lesion
- Surgery
- See Disease Characteristics
- No concurrent surgery
- Other
- Recovered from all prior therapy
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00096629
Start Date
November 1 2003
End Date
April 1 2018
Last Update
April 25 2018
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021