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
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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New York
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New York, New York, États-Unis, 10021
- Memorial Sloan Kettering Cancer Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
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Expérimental: 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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sécurité
Délai: 2 années
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2 années
|
|
feasibility
Délai: 2 years
|
2 years
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
antibody responses
Délai: 2 years
|
2 years
|
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anti-tumor response
Délai: 2 years
|
2 years
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Susan Slovin, MD, PhD, Memorial Sloan Kettering Cancer Center
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Tumeurs par type histologique
- Tumeurs
- Tumeurs urologiques
- Tumeurs urogénitales
- Tumeurs par site
- Maladies rénales
- Maladies urologiques
- Adénocarcinome
- Carcinome
- Tumeurs, glandulaires et épithéliales
- Tumeurs rénales
- Carcinome à cellules rénales
- Effets physiologiques des médicaments
- Facteurs immunologiques
- Vaccins
Autres numéros d'identification d'étude
- 03-125
- MSKCC-03125
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