- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00005992
Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Phase I Clinical Trial of Recombinant Prostate Specific Membrane Antigen (rPSMA)-Loaded Mature Autologous Dendritic Cells (CapPVax) for the Treatment of Metastatic Horomone Refractory Prostate Cancer
RATIONALE: Vaccines made from a person's peripheral stem cells may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
OBJECTIVES: I. Assess the safety of recombinant prostate-specific membrane antigen (rPSMA)-pulsed autologous dendritic cells (CaPVax) in patients with metastatic hormone-refractory prostate cancer. II. Determine the potential clinical response in patients treated with this regimen. III. Determine the effect of this treatment regimen on pain, physical function, and quality of life of these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients undergo a delayed hypersensitivity skin test with 3 common recall antigens. Autologous dendritic cells (DC) are pulsed with recombinant prostate-specific membrane antigen (rPSMA). Patients receive rPSMA-pulsed autologous DC (CaPVax) intradermally. Treatment repeats every 4 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CaPVax 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. Quality of life questionnaires are completed five times over the course of the study. Patients are followed at 3 months.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Tipo di studio
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
California
-
Los Angeles, California, Stati Uniti, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
-
-
Texas
-
Houston, Texas, Stati Uniti, 77030-4009
- University of Texas - MD Anderson Cancer Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS: Histologically confirmed metastatic hormone-refractory prostate cancer Castrate serum testosterone less than 30 ng/dL after antiandrogen withdrawal Progressing disease 50% increase in PSA level from the nadir PSA level confirmed twice and measured at least 2 weeks apart OR New bone pain or new lesion on bone scan OR Progression of soft tissue disease by CT or MRI Limited bone disease No more than 3 metastatic sites on bone scan and minimal symptoms No brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-1 Life expectancy: At least 1 year Hematopoietic: Hemoglobin greater than 12.5 g/dL Absolute lymphocyte count greater than 500/mm3 Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than 150,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT/SGPT less than 2 times upper limit of normal Hepatitis C negative Hepatitis B surface antigen and hepatitis B core antigen negative No uncontrolled liver disease Renal: Creatinine less than 2.5 mg/dL Creatinine clearance greater than 50 mL/min No uncontrolled renal disease Cardiovascular: No uncontrolled heart disease Immunologic: No history of severe asthma, anaphylaxis, or other serious adverse reaction to vaccines or any of the antigens included in skin test No immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis dermatomyositis, juvenile-onset insulin-dependent diabetes, or vasculitis Negative PPD skin test No prior BCG vaccination or tuberculosis exposure HIV negative Other: No impending untreated spinal cord compression or urinary outlet obstruction No other serious concurrent illness No other prior malignancy in past 2 years except curatively treated basal cell or squamous cell carcinoma of the skin
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic disease Endocrine therapy: See Disease Characteristics Hormonal therapy (except antiandrogens like LHRH) must be continued Radiotherapy: No prior radiotherapy for metastatic disease including strontium chloride Sr 89 Surgery: No prior splenectomy Other: No prior ketoconazole At least 4 weeks since prior immunosuppressives (e.g., prednisone or hydrocortisone) No prior investigational agents No concurrent medication that may affect immune function except nonprescription strength doses of nonsteroidal anti-inflammatory drugs, acetaminophen, or aspirin; low doses of antihistamine; normal doses of vitamins; or H2 blockers No more than 2 short courses (no more than 10 days per course) of antibiotics for treatment of minor infection in a 45 day span
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
Collaboratori e investigatori
Collaboratori
Investigatori
- Cattedra di studio: Arie Belldegrun, MD, FACS, Jonsson Comprehensive Cancer Center
Studiare le date dei record
Studia le date principali
Inizio studio
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UCLA-9909056-02B
- CDR0000067981 (Identificatore di registro: PDQ (Physician Data Query))
- NCI-G00-1802
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Cancro alla prostata
-
Zeba Ahmad, Ph.D.American Cancer Society, Inc.ReclutamentoCaregiving for CancerStati Uniti
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletatoAdenocarcinoma dell'intestino tenue | Adenocarcinoma dell'intestino tenue in stadio III AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIA AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIB AJCC v8 | Adenocarcinoma dell'intestino tenue stadio IV AJCC v8 | Ampolla di Vater... e altre condizioniStati Uniti
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...CompletatoStudio delle donne cinesi che non hanno aderito alle linee guida per lo screening mammografico dell'American Cancer SocietyStati Uniti
-
Institut Cancerologie de l'OuestAttivo, non reclutanteQualità della vita al lavoro | Professionisti paramedici | Toccare Massaggio | Cancer CenterFrancia
-
Emory UniversityNational Cancer Institute (NCI)RitiratoCancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nel cervello | Carcinoma mammario metastatico | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
-
Yonsei UniversityNon ancora reclutamentoRAS/BRAF Wild-Type Advanced Cancer MathementCorea, Repubblica di
-
NRG OncologyNational Cancer Institute (NCI)CompletatoCancro al seno in stadio anatomico IV AJCC v8 | Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nell'osso | Neoplasia maligna metastatica nei linfonodi | Neoplasia maligna metastatica nel fegato | Carcinoma mammario metastatico | Neoplasia maligna metastatica nel... e altre condizioniStati Uniti, Canada, Arabia Saudita, Corea del Sud
-
Jonsson Comprehensive Cancer CenterReclutamentoAdenocarcinoma prostatico | Cancro alla prostata in stadio II AJCC v8 | Fase I Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Jonsson Comprehensive Cancer CenterNovartis PharmaceuticalsReclutamentoCarcinoma della prostata | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Second Affiliated Hospital, School of Medicine,...Attivo, non reclutanteElettroacopuntura combinata con paclitaxel legato alla proteina e anticorpo PD-1 per il trattamento di seconda linea di HER2 negativo, PMMR/MSS Advanced Gastric CancerCina