Vaccine Therapy in Treating Patients With Kidney Cancer

NCT00096629 | Completed Phase 1

• 2 other identifiers: 03-125MSKCC-03125
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• safety

  2 years

• feasibility

  2 years

Secondary Outcomes (2)

• antibody responses

  2 years

• anti-tumor response

  2 years

Study Arms (2)

human PSMA

EXPERIMENTAL

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.

Biological: human prostate-specific membrane antigen plasmid DNA vaccine; Biological: mouse prostate-specific membrane antigen plasmid DNA vaccine

mouse PSMA

EXPERIMENTAL

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.

Biological: human prostate-specific membrane antigen plasmid DNA vaccine; Biological: mouse prostate-specific membrane antigen plasmid DNA vaccine

Interventions

human prostate-specific membrane antigen plasmid DNA vaccine BIOLOGICAL

human PSMA; mouse PSMA

mouse prostate-specific membrane antigen plasmid DNA vaccine BIOLOGICAL

human PSMA; mouse PSMA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Susan Slovin, MD, PhD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2004
• First Posted: November 15, 2004
• Study Start: November 1, 2003
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 25, 2018

Record last verified: 2018-04

Locations

US (1)