- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00003853
4'-Iodo-4'-Deoxydoxorubicin in Treating Patients With Primary Systemic Amyloidosis
Phase II Trial of 4'-IODO-4'-Deoxydoxorubicin in Primary Amyloidosis (AL)
RATIONALE: 4'-Iodo-4'-deoxydoxorubicin may improve organ dysfunction and ease symptoms caused by primary systemic amyloidosis.
PURPOSE: Phase II trial to study the effectiveness of 4'-iodo-4'-deoxydoxorubicin in treating patients who have primary systemic amyloidosis.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
OBJECTIVES: I. Evaluate the clinical efficacy of 4'-iodo-4'-deoxydoxorubicin in producing palliation of symptoms and/or improvement of organ dysfunction caused by organ infiltration by amyloid in patients with primary systemic amyloidosis. II. Assess the safety profile, with emphasis on cardiac safety, of this drug in these patients. III. Evaluate the time to progression of amyloidosis-associated clinical symptoms and/or organ dysfunction, duration of response, and survival of these patients on this regimen.
OUTLINE: Patients receive 4'-iodo-4'-deoxydoxorubicin IV over 1 hour once a week for 4 weeks. Courses are repeated every 12 weeks. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 1 year.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Pavia, Italia, 27100
- University of Pavia
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72205
- University of Arkansas for Medical Sciences
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Minnesota
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic Cancer Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS: Histochemically proven primary systemic amyloidosis (AL) No presence of non-AL amyloidosis No amyloid-specific syndrome (e.g., skin purpura or carpal tunnel syndrome) as only evidence of disease No vascular amyloid only in a bone marrow biopsy specimen or in a plasmacytoma Must have symptomatic organ involvement with amyloid (e.g., liver, mild cardiac, renal, or soft tissue involvement, or grade 1 or 2 peripheral neuropathy) Demonstrable M-protein in the serum/urine OR Clonal population of plasma cells in the bone marrow OR Immunohistochemical stain with anti-light chain antisera of amyloid fibrils No clinically overt multiple myeloma (i.e., monoclonal BMPC greater than 20% and at least one of the following: bone lesions, anemia, or hypercalcemia)
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Total bilirubin less than 2.0 mg/dL OR Direct bilirubin no greater than 1.0 mg/dL Alkaline phosphatase no greater than 4 times upper limit of normal (ULN) ALT or AST no greater than 3 times ULN Renal: Creatinine clearance greater than 40 mL/min Cardiovascular: Echocardiographic ejection fraction greater than 50% At least 3 years since prior enzyme documented myocardial infarction Interventricular septal thickness no greater than 20 mm No New York Heart Association class III or IV heart failure No grade 2 or 3 A-V block No chronic atrial fibrillation No sustained (greater than 30 seconds) ventricular tachycardia or frequent episodes (greater than 20 in 24 hours) of nonsustained ventricular tachycardia or ventricular pairs, detected by 24-hour ambulatory electrocardiographic monitoring Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV positive allowed No uncontrolled infection No severe diarrhea not controllable with medication or that requires total parenteral nutrition No other concurrent active malignancy except nonmelanoma skin cancer or cervical cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior interferon alfa Chemotherapy: No prior anthracyclines greater than 120 mg/m2 At least 6 weeks since prior melphalan or other alkylating agents Endocrine therapy: At least 6 weeks since prior high dose dexamethasone Radiotherapy: Not specified Surgery: Not specified
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Morie A. Gertz, MD, Mayo Clinic
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
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
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattia cardiovascolare
- Malattie vascolari
- Malattie metaboliche
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Disturbi immunoproliferativi
- Malattie ematologiche
- Disturbi emorragici
- Disturbi emostatici
- Paraproteinemie
- Disturbi delle proteine del sangue
- Carenze di proteostasi
- Mieloma multiplo
- Neoplasie, plasmacellule
- Amiloidosi a catena leggera delle immunoglobuline
- Amiloidosi
- Plasmocitoma
- Agenti antineoplastici
- Antibiotici, Antineoplastici
- Esorubicina
Altri numeri di identificazione dello studio
- CDR0000067016
- P30CA015083 (Sovvenzione/contratto NIH degli Stati Uniti)
- 988003 (Altro identificatore: Mayo Clinic Cancer Center)
- T98-0003 (Altro identificatore: NCI Protocol)
- 302-99 (Altro identificatore: Mayo Clinic IRB)
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 .
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