Clinical trial NCT00096629: 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
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-11-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: safety
timeFrame: 2 years
measure: feasibility
timeFrame: 2 years
Secondary outcomes:
measure: antibody responses
timeFrame: 2 years
measure: anti-tumor response
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Susan Slovin, MD, PhD
role: STUDY_CHAIR
References: