Leukemia Clinical Trial
Official title:
A Phase I Dose Escalation Trial of Clofarabine in Addition to Topotecan, Vinorelbine, Thiotepa, and Dexamethasone in Pediatric Patients With Relapsed or Refractory Acute Leukemia
RATIONALE: Drugs used in chemotherapy, such as clofarabine, topotecan, vinorelbine,
thiotepa, and dexamethasone, work in different ways to stop the growth of cancer cells,
either by killing the cells or by stopping them from dividing. Giving more than one drug
(combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when
given together with topotecan, vinorelbine, thiotepa, and dexamethasone in treating young
patients with relapsed or refractory acute leukemia.
OBJECTIVES:
- Determine the maximum tolerated dose of clofarabine when administered in combination
with topotecan hydrochloride, vinorelbine ditartrate, thiotepa, and dexamethasone in
young patients with relapsed or refractory acute leukemia.
- Evaluate the antileukemic potential of this regimen in these patients.
- Evaluate the incidence and severity of treatment-related morbidity and mortality in
patients treated with this regimen.
- Develop a new reinduction treatment regimen that will result in a patient clinical
response with as little residual disease as possible to permit a bone marrow
transplantation while in subsequent remission; maintain the response long enough to
identify an appropriate stem cell donor; and permit the patient to undergo a stem cell
transplantation free of infections and without vital organ dysfunction.
OUTLINE: This is a nonrandomized, prospective, dose-escalation study of clofarabine.
Patients receive topotecan hydrochloride IV continuously over 120 hours on days 0-4;
vinorelbine ditartrate over 6-10 minutes on days 0, 7, and 14; thiotepa IV over 4 hours on
day 2; clofarabine IV over 2 hours on days 3-7; and oral or IV dexamethasone 3 times daily
on days 3 and 7-13 and then on day 3 only thereafter. Patients also receive filgrastim
(G-CSF) subcutaneously once daily beginning on day 8 and continuing until blood counts
recover. Treatment repeats every 21 days in the absence of disease progression or
unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of clofarabine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience
dose-limiting toxicity OR the dose preceding that at which 2 of 3 patients experience
dose-limiting toxicity. At least 6 patients are treated at the MTD.
After completion of study treatment, patients are followed once a week for 4 weeks, twice a
month for 6 months, and then once a month for 2 years.
PROJECTED ACCRUAL: A total of 23 patients will be accrued for this study.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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