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VNP40101M in Treating Patients With Acute Myelogenous Leukemia or High-Risk Myelodysplasia

17 luglio 2013 aggiornato da: Vion Pharmaceuticals

A Phase II Study of VNP40101M For Patients With Acute Myelogenous Leukemia Or High-Risk Myelodysplasia

RATIONALE: Drugs used in chemotherapy, such as VNP40101M and hydroxyurea, work in different ways to stop cancer cells from dividing so they stop growing or die. Hydroxyurea may help VNP40101M kill more cancer cells by making cancer cells more sensitive to the drug.

PURPOSE: This phase II trial is studying how well giving VNP40101M with hydroxyurea works in treating patients with acute myelogenous leukemia or high-risk myelodysplasia.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

OBJECTIVES:

Determine the complete response rate to VNP40101M in patients with acute myelogenous leukemia or high-risk myelodysplasia .
Determine the toxic effects of this regimen in these patients.
Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is an open-label, multicenter study. Patients are stratified to acute myelogenous leukemia (AML) or high risk myelodysplasia (MDS) patients ≥ 60 years old with no prior treatment vs AML patients any age in first relapse. (AML patients any age in first relapse closed to accrual 06/09/05).

Patients receive VNP40101M IV over 30 minutes once on day 1 (course 1).

Four to five weeks after the first course, patients undergo bone marrow aspiration and biopsy. If the bone marrow is improved but contains residual leukemia, patients receive a second course of VNP40101M (at the same dose as in course 1). If patients achieve complete response (CR), or partial CR after the first or second course, a consolidation course may be given comprising VNP40101M at a reduced dose.

Patients are followed monthly for 6 months, every 2 months for 12 months, and then every 3 months for 18 months .

PROJECTED ACCRUAL: A total of 230 patients (100 with acute myelogenous leukemia (AML) or high-risk myelodysplasia and 130 with AML in first relapse) will be accrued for this study.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

230

Fase

Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Francia
- - Marseille, Francia, 13273
    - Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Regno Unito
- England
  - London, England, Regno Unito, SE5 8RX
    - King's College Hospital
Stati Uniti
- Maryland
  - Baltimore, Maryland, Stati Uniti, 21231
    - Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- North Carolina
  - Durham, North Carolina, Stati Uniti, 27710
    - Duke Comprehensive Cancer Center
- Texas
  - Houston, Texas, Stati Uniti, 77030-4009
    - M.D. Anderson Cancer Center at University of Texas

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

DISEASE CHARACTERISTICS:

Histologically confirmed diagnosis of 1 of the following:
- Acute myelogenous leukemia (AML), meeting the following criteria:
  - In first relapse after first treatment-induced complete remission (CR) (closed to accrual as of 06/09/05)
    - Duration of first CR less than 12 months
    - No prior treatment for first relapse except hydroxyurea
  - FAB type M0, M1, M2, M4-7
  - No acute promyelocytic leukemia
  - No prior treatment with a standard induction regimen containing cytotoxic agents* (for patients 60 years of age or older)
- High-risk myelodysplasia, meeting the following criteria:
  - 60 years of age and over
  - No prior cytotoxic chemotherapy* except hydroxyurea
  - Prior gemtuzumab ozogamicin allowed
  - High risk defined as International Prognostic Scoring System score ≥ 1.5, defined by cytogenetics, % marrow blasts, and lineage cytopenias NOTE: *Prior low-dose, single-agent cytarabine, decitabine, or azacitidine not considered prior cytotoxic chemotherapy

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Bilirubin ≤ 2.0 mg/dL
ALT or AST ≤ 5 times upper limit of normal
Chronic hepatitis allowed

Renal

Creatinine ≤ 2.0 mg/dL

Cardiovascular

No myocardial infarction within the past 3 months
No symptomatic coronary artery disease
No uncontrolled arrhythmias
No uncontrolled congestive heart failure
No other active heart disease

Other

No uncontrolled active infection
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

Up to 4 leukapheresis procedures allowed during the first 15 days of study treatment

Chemotherapy

See Disease Characteristics
Concurrent additional hydroxyurea (maximum dose of 5 g daily for up to 4 days) allowed between days 4 and 15 of each study course to control elevated blast levels

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Other

Recovered from all prior therapy
At least 72 hours since prior anti-leukemic treatment with a non-cytotoxic agent
No concurrent disulfiram (Antabuse)
No other concurrent anticancer drugs except anagrelide within the first 15 days of study treatment to control elevated platelet counts
No other concurrent treatment for leukemia, except hydroxyurea used during study treatment
No other concurrent investigational drugs

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Mascheramento: Nessuno (etichetta aperta)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Farmacocinetica
Tasso di risposta completo
Effetti tossici

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Vion Pharmaceuticals

Investigatori

Cattedra di studio: Francis J. Giles, MD, M.D. Anderson Cancer Center

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Gerson SL, Karp J, Rizzieri D, et al.: Low levels of pre-treatment O6-alkylguanine transferase (AGT) in patients with AML correlate with response to Cloretazine® (VNP40101M) induction therapy. [Abstract] American Association for Cancer Research: 98th Annual Meeting, April 14-18, 2007, Los Angeles, CA. A-2640, 2007.
Giles F, Rizzieri D, Karp J, Vey N, Ravandi F, Faderl S, Khan KD, Verhoef G, Wijermans P, Advani A, Roboz G, Kantarjian H, Bilgrami SF, Ferrant A, Daenen SM, Karsten V, Cahill A, Albitar M, Mufti G, O'Brien S. Cloretazine (VNP40101M), a novel sulfonylhydrazine alkylating agent, in patients age 60 years or older with previously untreated acute myeloid leukemia. J Clin Oncol. 2007 Jan 1;25(1):25-31. doi: 10.1200/JCO.2006.07.0961. Epub 2006 Dec 4.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2005

Completamento primario (Effettivo)

1 gennaio 2007

Completamento dello studio (Effettivo)

1 agosto 2008

Date di iscrizione allo studio

Primo inviato

14 maggio 2004

Primo inviato che soddisfa i criteri di controllo qualità