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Vaccine Therapy in Treating Patients With Kidney Cancer

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
human prostate-specific membrane antigen plasmid DNA vaccine
mouse prostate-specific membrane antigen plasmid DNA vaccine
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage I renal cell cancer, stage II renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

human PSMA

mouse PSMA

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

safety
feasibility

Secondary Outcome Measures

antibody responses
anti-tumor response

Full Information

First Posted
November 12, 2004
Last Updated
April 24, 2018
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00096629
Brief Title
Vaccine Therapy in Treating Patients With Kidney Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
human PSMA
Arm Type
Experimental
Arm Description
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.
Arm Title
mouse PSMA
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
human prostate-specific membrane antigen plasmid DNA vaccine
Intervention Type
Biological
Intervention Name(s)
mouse prostate-specific membrane antigen plasmid DNA vaccine
Primary Outcome Measure Information:
Title
safety
Time Frame
2 years
Title
feasibility
Time Frame
2 years
Secondary Outcome Measure Information:
Title
antibody responses
Time Frame
2 years
Title
anti-tumor response
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Slovin, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

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Vaccine Therapy in Treating Patients With Kidney Cancer

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