Vaccine Therapy in Treating Patients With Kidney Cancer

NCT ID: NCT00096629

Last Updated: 2018-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2018-04-30

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.

Conditions

Kidney Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

human PSMA

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.

Group Type: EXPERIMENTAL

human prostate-specific membrane antigen plasmid DNA vaccine

Intervention Type: BIOLOGICAL

mouse prostate-specific membrane antigen plasmid DNA vaccine

Intervention Type: BIOLOGICAL

mouse PSMA

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.

Group Type: EXPERIMENTAL

human prostate-specific membrane antigen plasmid DNA vaccine

Intervention Type: BIOLOGICAL

mouse prostate-specific membrane antigen plasmid DNA vaccine

Intervention Type: BIOLOGICAL

Interventions

human prostate-specific membrane antigen plasmid DNA vaccine

Intervention Type: BIOLOGICAL

mouse prostate-specific membrane antigen plasmid DNA vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Slovin, MD, PhD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

MSKCC-03125

Identifier Type: -

Identifier Source: secondary_id

03-125

Identifier Type: -

Identifier Source: org_study_id