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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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New York
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New York, New York, Verenigde Staten, 10021
- Memorial Sloan Kettering Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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veiligheid
Tijdsspanne: 2 jaar
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2 jaar
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feasibility
Tijdsspanne: 2 years
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2 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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antibody responses
Tijdsspanne: 2 years
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2 years
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anti-tumor response
Tijdsspanne: 2 years
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2 years
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Studie stoel: Susan Slovin, MD, PhD, Memorial Sloan Kettering Cancer Center
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per histologisch type
- Neoplasmata
- Urologische neoplasmata
- Urogenitale neoplasmata
- Neoplasmata per site
- Nier Ziekten
- Urologische ziekten
- Adenocarcinoom
- Carcinoom
- Neoplasmata, glandulair en epitheel
- Nierneoplasmata
- Carcinoom, niercel
- Fysiologische effecten van medicijnen
- Immunologische factoren
- Vaccins
Andere studie-ID-nummers
- 03-125
- MSKCC-03125
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