• Return to search results
• Start new search

Investigator(s):
Brigitte Widemann, M.D. Principal Investigator Phone: 301-496-7387 widemanb@pbmac.nci.nih.gov
Referral Contact(s):
Pediatric Oncology  Phone: 1-877-624-4878 (Toll free)

---

Primary Eligibility:

• Confirmed diagnosis of relapsed or refractory leukemia
• Patients with refractory or second or greater relapsed leukemia must have greater than 25% blasts in the bone marrow (M3 bone marrow); active extramedullary disease (except for leptomeningeal disease) may also be present
• ≥ 12 months and ≤ 21 years of age
• No active CNS leukemia
• Platelet count ≥ 20,000/μL (may receive platelet transfusions) and hemoglobin of ≥ 8 gm/dL (may receive RBC transfusions)
• Patients’ current disease state must be one that has relapsed after or failed to respond to frontline curative therapy and no potentially curative treatment options (surgery, radiation therapy, chemotherapy, or any combination of these modalities) are available
• Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
• Patients > 10 years of age must have a Karnofsky performance level ≥ 50%, children ≤ 10 years of age must have a Lansky performance level ≥ 50%; patients who are unable to walk because of paralysis or weakness but are up in a wheelchair will be considered ambulatory for the purpose of calculating the performance score
• Patients must have an age-adjusted normal serum creatinine OR a creatinine clearance ≥ 60 mL/min/1.73 m²
• Bilirubin < 1.5 x the upper limit of normal (ULN), SGPT (ALT) and SGOT (AST) < 2.5 x ULN
• No clinically significant unrelated systemic illness, such as serious infection, hepatic, renal or other organ dysfunction that, in the judgment of the Principal or Associate Investigators of this protocol, would compromise the patient’s ability to tolerate the investigational agent or is likely to interfere with the study procedures or results
• No preexisting grade 2 or greater sensory neuropathy
• Not currently receiving St. John’s Wort
• Not pregnant or nursing; negative pregnancy test; fertile patients must use effective contraception during and for 2 weeks after completion of study treatment

---

Treatment Plan:

• BMS-247550 will be given intravenously over 1 hour daily for 5 consecutive days every 21 days (21-day treatment cycle)
• Treatment cycles can be repeated immediately upon completion of the previous 21-day cycle provided that the patient has recovered from the toxicities of the previous cycle
• Treatment cycles can be extended to 28 days to allow for patients to recover from toxicity
• Detailed pharmacokinetic and pharmacodynamic studies will be performed during the first treatment cycle

---

Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 11/11/08
Updated: 7/31/08