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Sorafenib in Combination With Cytarabine and Clofarabine in Patients With Refractory or Relapsed Hematologic Malignancies

2014-08-27 03:21:56 | BioPortfolio

Summary

This is a Phase I study to characterize the toxicity profile of sorafenib and to determine the maximum tolerated dose of sorafenib when given in combination with cytarabine and clofarabine and determine the feasibility of administering this drug combination in patients with relapsed or refractory hematologic malignancies including acute myeloid leukemia (ALML), acute promyelocytic leukemia (APL), acute lymphoblastic leukemia (ALL), infantile leukemia (both either AML and/or ALL). AML with prior myelodysplastic syndrome (MDS), myelodysplastic syndrome (MDS), myelodysplastic/myeloproliferative neoplasms, chronic myeloid leukemia (CML), in blastic crisis, and or biphenotypic leukemia.

Description

Research is performed in patients with age of ≥ 0 months old and < 31 years old and has 2 strata:

Stratum1: Participants who did not receive hematopoietic stem cell transplantation within 6 months or did not have fungal infection within a month In course 1, sorafenib will be given orally (PO) twice daily starting on day 1 until day 7 (1 week) for pharmacokinetic and pharmacodynamic assessment (sorafenib phase). Inter-patient dose de-escalation of sorafenib will be performed based on tolerability and toxicity. On day 8, clofarabine and cytarabine will be administered intravenously (IV) in combination with twice daily sorafenib. Sorafenib will be given up to 28 days in 1 course. Cytarabine and clofarabine may be given starting before day 8 when the treating physician feels it is necessary after consulting with the primary investigator based on the participant's clinical condition. Intrathecal (IT) methotrexate (age-adjusted doses) with leucovorin rescue can be given on day 8. Participants with central nervous system (CNS) disease can receive IT therapy weekly until the cerebrospinal fluid (CSF) becomes free of leukemia (minimum of 4 doses).

Response evaluation will be performed on day 22 (or 15 days after initiation of cytarabine and clofarabine) in the first course. One course of therapy will be for 28 days unless disease progression is seen. Participants may receive subsequent courses (up to 4 courses) if there is no disease progression or unacceptable toxicity. Sorafenib is given for 2 days in the subsequent courses, and sorafenib, cytarabine and clofarabine will be administered starting on day 3 of the courses. Sorafenib will be given up to 28 days in a course.

Stratum 2: Participants who received hematopoietic stem cell transplantation within 6 months or had fungal infection within a month Due to anticipated risks of severe myelosuppression and infection, the clofarabine dose will be reduced. The same doses of sorafenib and cytarabine as in stratum 1 will be used in stratum 2.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Acute Myeloid Leukemia

Intervention

Sorafenib, Cytarabine, Clofarabine

Location

St. Jude Children's Research Hospital
Memphis
Tennessee
United States
38105

Status

Active, not recruiting

Source

St. Jude Children's Research Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:21:56-0400

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