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6-Hydroxymethylacylfulvene in Treating Patients With Refractory Myelodysplastic Syndrome, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, or Blastic Phase Chronic Myelogenous Leukemia

7. februar 2013 oppdatert av: National Cancer Institute (NCI)

Phase I Study of MGI-114 (NSC#683863) in Patients With Refractory Myelodysplastic Syndromes, Acute Leukemia and Chronic Myelogenous Leukemia in Blastic Phase (CML-BP)

Phase I trial to study the effectiveness of 6-hydroxymethylacylfulvene in treating patients who have refractory myelodysplastic syndrome, acute myeloid leukemia, acute lymphocytic leukemia, or blastic phase chronic myelogenous leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

I. Determine the maximum tolerated dose for 6-hydroxymethylacylfulvene in patients with refractory myelodysplastic syndrome, acute myeloid leukemia, acute lymphocytic leukemia, or blastic phase chronic myelogenous leukemia.

II. Determine the qualitative and quantitative toxicities of this treatment in these patients.

III. Determine the duration and reversibility of the qualitative and quantitative toxicities of this treatment in these patients.

IV. Evaluate, in a preliminary manner, the antileukemic activity of this treatment in these patients.

V. Assess relative mRNA levels of selected NER genes (ERCC1, ERCC2, and ERCC3) in tumor tissues of patients treated with this regimen and correlate with clinical outcome.

OUTLINE: This is a dose escalation study.

Patients receive 6-hydroxymethylacylfulvene (HMAF) IV over 5 minutes on days 1-5. Treatment repeats every 3-4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3 patients receive escalating doses of HMAF. The maximum tolerated dose is defined as the dose at which dose limiting toxicity occurs in at least 40% of patients.

Patients are followed every 3 months for 1 year and then every 6 months thereafter.

Studietype

Intervensjonell

Registrering (Faktiske)

25

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Texas
      • Houston, Texas, Forente stater, 77030
        • University of Texas - MD Anderson Cancer Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Diagnosis of refractory myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), acute lymphocytic leukemia, or blastic phase chronic myelogenous leukemia MDS and AML include:

    • First salvage with primary refractory disease or first complete remission of no more than 12 months
    • Second or greater salvage
  • After the maximum tolerated dose is determined, AML patients with an intermediate prognosis (i.e., complete remission of more than 12 months, but less than 24 months) are eligible
  • No candidates for curative therapies such as allogeneic bone marrow transplantation

PATIENT CHARACTERISTICS:

  • Age: 18 and over
  • Performance status: Zubrod 0-2
  • Bilirubin no greater than 1.5 mg/dL
  • Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min
  • No active congestive heart failure
  • No uncontrolled angina
  • No myocardial infarction within past 6 months
  • No concurrent grade 4 infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No overt psychosis, mental disability, or other incompetency that would preclude obtaining informed consent
  • No life threatening nonmalignant illness

PRIOR CONCURRENT THERAPY:

  • At least 2 weeks since prior biologic therapy and recovered
  • No concurrent systemic anticancer biologic therapy
  • At least 2 weeks since other prior chemotherapy and recovered
  • Concurrent hydroxyurea allowed if needed to control blast counts
  • No concurrent systemic anticancer chemotherapy
  • At least 2 weeks since prior endocrine therapy and recovered
  • Concurrent corticosteroids allowed if needed to control blast counts
  • At least 2 weeks since prior radiotherapy and recovered
  • No concurrent systemic radiotherapy
  • No concurrent surgery
  • At least 3 weeks since other prior investigational drugs (including analgesics or antiemetics) and recovered
  • No other concurrent investigational drugs

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm I
Patients receive 6-hydroxymethylacylfulvene (HMAF) IV over 5 minutes on days 1-5. Treatment repeats every 3-4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3 patients receive escalating doses of HMAF. The maximum tolerated dose is defined as the dose at which dose limiting toxicity occurs in at least 40% of patients.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studiestol: Francis J. Giles, MD, M.D. Anderson Cancer Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 1999

Primær fullføring (Faktiske)

1. oktober 2000

Datoer for studieregistrering

Først innsendt

1. november 1999

Først innsendt som oppfylte QC-kriteriene

2. juni 2004

Først lagt ut (Anslag)

3. juni 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

8. februar 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. februar 2013

Sist bekreftet

1. januar 2001

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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