- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00003997
6-Hydroxymethylacylfulvene in Treating Patients With Refractory Myelodysplastic Syndrome, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, or Blastic Phase Chronic Myelogenous Leukemia
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)
Studieoversikt
Status
Forhold
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
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Texas
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Houston, Texas, Forente stater, 77030
- University of Texas - MD Anderson Cancer Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
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.
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Francis J. Giles, MD, M.D. Anderson Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Neoplasmer etter histologisk type
- Neoplasmer
- Sykdom
- Benmargssykdommer
- Hematologiske sykdommer
- Myeloproliferative lidelser
- Neoplastiske prosesser
- Forstadier til kreft
- Celletransformasjon, neoplastisk
- Karsinogenese
- Syndrom
- Myelodysplastiske syndromer
- Leukemi
- Leukemi, myeloid
- Preleukemi
- Leukemi, myelogen, kronisk, BCR-ABL positiv
- Blast krise
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Irofulven
Andre studie-ID-numre
- NCI-2012-02309
- MDA-ID-99060
- NCI-T99-0043
- CDR0000067207 (Registeridentifikator: PDQ (Physician Data Query))
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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