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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Kidney Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

safety

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Susan Slovin, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

03-125

NCT ID:

NCT00096629

Start Date:

November 2003

Completion Date:

November 2013

Related Keywords:

  • Kidney Cancer
  • recurrent renal cell cancer
  • stage I renal cell cancer
  • stage II renal cell cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021