TerminatedPhase 1/2

Clofarabine, Cytarabine, and G-CSF in Treating Patients With Myelodysplastic Syndromes

Stopped: Genzyme discontinued Funding

United States2 participantsStarted 2007-05-07

Plain-language summary

RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in bone marrow or in peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving clofarabine and cytarabine together with G-CSF may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine and to see how well it works when given together with cytarabine and G-CSF in treating patients with myelodysplastic syndromes.

Who can participate

Age range19 Years – 120 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Confirmed pathologic diagnosis of myelodysplastic syndromes * International Prognostic Scoring System score of intermediate-2 or high-riskFailed or progressed after 1 prior FDA-approved treatment for MDS OR refused the FDA-approved treatment * Not a candidate for intensive or standard chemotherapy or stem cell transplantation, as determined by the treating physician * ECOG performance status 0-2 * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST or ALT ≤ 3 times ULN * Creatinine \< 2.0 mg/dL * Fertile patients must use effective contraception Exclusion Criteria: * Not pregnant or nursing * No comorbidity or condition that, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol or that would decrease life expectancy to \< 3 months * No active, serious infection not controlled by oral or IV antibiotics

What they're measuring

Maximum Tolerated Dose of Clofarabine (Phase I)

Timeframe: 7 months

Presence of Hematologic Response (Phase II)

Timeframe: Following phase I, responses must last at least 8 weeks.

Trial details

NCT IDNCT00503880

SponsorUniversity of Nebraska

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-10-13

Results submitted2018-01-19