Leukemia Clinical Trial
Official title:
A Dose Finding Study of the Safety of Gemtuzumab Ozogamicin Combined With Conventional Chemotherapy for Patients With Relapsed or Refractory Acute Myeloid Leukemia
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from
dividing so they stop growing or die. Monoclonal antibodies such as gemtuzumab ozogamicin
can locate cancer cells and either kill them or deliver cancer-killing substances to them
without harming normal cells. Combining monoclonal antibody therapy with combination
chemotherapy may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of combining gemtuzumab ozogamicin with
combination chemotherapy in treating children who have relapsed or refractory acute myeloid
leukemia or myelodysplastic syndrome.
OBJECTIVES:
- Determine the safety and maximum tolerated dose of gemtuzumab ozogamicin in combination
with conventional chemotherapy in patients with relapsed or refractory acute myeloid
leukemia or myelodysplastic syndromes.
- Determine the efficacy of this regimen in these patients.
- Correlate the likelihood of leukemic blast cells to undergo apoptosis in vitro with the
efficacy of this regimen in these patients.
- Correlate drug resistance as manifested by dye efflux or multiple drug resistance-1
expression by leukemic blast cells with the efficacy of this regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study of gemtuzumab ozogamicin. Patients are
assigned by cohort to 1 of 2 treatment regimens.
- Regimen A: Patients receive cytarabine IV over 2 hours every 12 hours on days 1-4,
mitoxantrone IV over 1 hour on days 3-6, and gemtuzumab ozogamicin IV over 2 hours on
day 7.
- Regimen B: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 2, 8,
and 9, asparaginase intramuscularly on days 2 and 9, and gemtuzumab ozogamicin IV over
2 hours on day 3.
Cohorts of 3-6 patients receive de-escalating doses of gemtuzumab ozogamicin until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose below that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for 6 months, every 2 months for 6 months, every 6 months for
2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study within 1.5 years.
;
Primary Purpose: Treatment
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