Vaccine Therapy in Treating Patients With Kidney Cancer

Phase 1

Completed

• Conditions: Kidney Cancer
• Interventions: Biological: human prostate-specific membrane antigen plasmid DNA vaccine; Biological: mouse prostate-specific membrane antigen plasmid DNA vaccine

• Registration Number: NCT00096629
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2004-11-12
• Study First Submitted QC: 2004-11-12
• Study First Posted: 2004-11-15
• Status Verified: 2018-04
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-24
• Last Update Posted: 2018-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
human PSMA	human prostate-specific membrane antigen plasmid DNA vaccine	Patients will receive a total of 6 vaccinations via the intramuscular route. Sites of injection should have intact lymphatic drainage. Groups of six patients will be randomized at each dose level, 3 for each arm, to receive either three immunizations with mouse PSMA followed by three immunizations with human PSMA or three immunizations with human PSMA followed by three immunizations with mouse PSMA.
human PSMA	mouse prostate-specific membrane antigen plasmid DNA vaccine	Patients will receive a total of 6 vaccinations via the intramuscular route. Sites of injection should have intact lymphatic drainage. Groups of six patients will be randomized at each dose level, 3 for each arm, to receive either three immunizations with mouse PSMA followed by three immunizations with human PSMA or three immunizations with human PSMA followed by three immunizations with mouse PSMA.
mouse PSMA	mouse prostate-specific membrane antigen plasmid DNA vaccine	Patients will receive a total of 6 vaccinations via the intramuscular route. Sites of injection should have intact lymphatic drainage. Groups of six patients will be randomized at each dose level, 3 for each arm, to receive either three immunizations with mouse PSMA followed by three immunizations with human PSMA or three immunizations with human PSMA followed by three immunizations with mouse PSMA.
mouse PSMA	human prostate-specific membrane antigen plasmid DNA vaccine	Patients will receive a total of 6 vaccinations via the intramuscular route. Sites of injection should have intact lymphatic drainage. Groups of six patients will be randomized at each dose level, 3 for each arm, to receive either three immunizations with mouse PSMA followed by three immunizations with human PSMA or three immunizations with human PSMA followed by three immunizations with mouse PSMA.

Primary Outcome Measures

Name	Time	Method
safety	2 years
feasibility	2 years

Secondary Outcome Measures

Name	Time	Method
antibody responses	2 years
anti-tumor response	2 years

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States