Expired Study
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New York, New York 10021


Purpose:

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 in treating patients with kidney cancer.


Study summary:

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 maximum tolerated dose of this regimen in these patients. - Determine antibody responses to human PSMA in patients treated with this regimen. Secondary - Assess antitumor response in patients treated with this regimen. OUTLINE: This is a randomized, dose-escalation study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive human prostate-specific membrane antigen (PSMA) DNA vaccine intramuscularly (IM) once every 3 weeks for 3 doses (doses 1-3). Patients then receive mouse PSMA DNA vaccine IM once every 3 weeks for 3 doses (doses 4-6). - Arm II: Patients receive mouse PSMA DNA vaccine IM once every 3 weeks for 3 doses (doses 1-3). Patients then receive human PSMA DNA vaccine IM once every 3 weeks for 3 doses (doses 4-6). In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional booster vaccinations with the second form of PSMA DNA vaccine received (for doses 4-6) every 8 weeks for up to 4 additional doses. Cohorts of 3-6 patients per arm receive escalating doses of human and mouse PSMA DNA vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for 2 years.


Criteria:

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


NCT ID:

NCT00096629


Primary Contact:

Study Chair
Susan Slovin, MD, PhD
Memorial Sloan Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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