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Vaccine Therapy in Treating Patients With Kidney Cancer

Injection of Renal Cell Carcinoma Patients With Human and Mouse Prostate Specific Membrane Antigen (PSMA) DNA: A Phase I Trial to Assess Safety and Immune Response

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00096629
Enrollment
15
Registered
2004-11-15
Start date
2003-11-30
Completion date
2018-04-30
Last updated
2018-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer

Keywords

recurrent renal cell cancer, stage I renal cell cancer, stage II renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer

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 in treating patients with kidney cancer.

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 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.

Interventions

BIOLOGICALhuman prostate-specific membrane antigen plasmid DNA vaccine
BIOLOGICALmouse prostate-specific membrane antigen plasmid DNA vaccine

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
safety2 years
feasibility2 years

Secondary

MeasureTime frame
antibody responses2 years
anti-tumor response2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026