Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Kidney Cancer
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
NCT00096629CI-TRIAL-00032656completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| human prostate-specific membrane antigen plasmid DNA vaccine | Biological | — | UNRESOLVED |
| mouse prostate-specific membrane antigen plasmid DNA vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- human PSMA
- 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.
- interventionNames
- Biological: human prostate-specific membrane antigen plasmid DNA vaccine
- Biological: mouse prostate-specific membrane antigen plasmid DNA vaccine
- type
- EXPERIMENTAL
- label
- mouse PSMA
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.