- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Texas
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Houston, Texas, Forenede Stater, 77030
- University of Texas - MD Anderson Cancer Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Francis J. Giles, MD, M.D. Anderson Cancer Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Neoplasmer efter histologisk type
- Neoplasmer
- Sygdom
- Knoglemarvssygdomme
- Hæmatologiske sygdomme
- Myeloproliferative lidelser
- Neoplastiske processer
- Forstadier til kræft
- Celletransformation, neoplastisk
- Karcinogenese
- Syndrom
- Myelodysplastiske syndromer
- Leukæmi
- Leukæmi, myeloid
- Præleukæmi
- Leukæmi, myelogen, kronisk, BCR-ABL positiv
- Blast krise
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Irofulven
Andre undersøgelses-id-numre
- NCI-2012-02309
- MDA-ID-99060
- NCI-T99-0043
- CDR0000067207 (Registry Identifier: PDQ (Physician Data Query))
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