Vaccine Therapy in Treating Patients With Kidney Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00096629
First received: November 12, 2004
Last updated: March 11, 2014
Last verified: March 2014
  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.


Condition Intervention Phase
Kidney Cancer
Biological: human prostate-specific membrane antigen plasmid DNA vaccine
Biological: mouse prostate-specific membrane antigen plasmid DNA vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • feasibility [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • antibody responses [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • anti-tumor response [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: November 2003
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Biological: human prostate-specific membrane antigen plasmid DNA vaccine Biological: mouse prostate-specific membrane antigen plasmid DNA vaccine
Experimental: 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.
Biological: human prostate-specific membrane antigen plasmid DNA vaccine Biological: mouse prostate-specific membrane antigen plasmid DNA vaccine

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096629

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Susan Slovin, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00096629     History of Changes
Other Study ID Numbers: 03-125, MSKCC-03125
Study First Received: November 12, 2004
Last Updated: March 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
recurrent renal cell cancer
stage I renal cell cancer
stage II renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014