Leukemia Clinical Trial
Official title:
A Pilot Clinical Trial of Mitomycin C Modulation of Multidrug Resistance Proteins and a Phase I Evaluation of Mitomycin C and Mitoxantrone in Patients With Acute Myelogenous Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Some cancers become resistant to chemotherapy drugs. Combining
mitomycin with a chemotherapy drug may reduce resistance to the drug and allow the cancer
cells to be killed.
PURPOSE: Phase I trial to study the effectiveness of mitomycin and mitoxantrone in treating
patients with acute myelogenous leukemia and to determine whether mitomycin can reduce the
cancer's resistance to chemotherapy.
OBJECTIVES: I. Determine whether a single mitomycin C treatment will suppress expression of
one or more proteins associated with the multidrug resistance phenotype in leukemia cells of
patients with refractory acute myelogenous leukemia. II. Determine the maximum tolerated dose
of a combination of mitomycin C followed 72 hours later by a single dose of mitoxantrone in
patients with acute myelogenous leukemia with GM-CSF support. III. Determine the toxicity
profile and pharmokinetics for these combinations of mitomycin C and mitoxantrone. IV.
Determine the ability of this regimen to induce complete response in patients with primary
resistant or refractory acute myelogenous leukemia.
OUTLINE: Patients receive mitomycin C by IV bolus on day 1 of treatment. Patients receive
mitoxantrone beginning on day 4. One patient each is entered at the first and second dose
levels. Dose escalation of mitoxantrone continues in the absence of toxicity. If the patient
experiences toxicity at level 1 or 2, then 2 additional patients are entered at that tier.
Three patients are entered at all subsequent tiers. At these tiers, if no toxicity is
observed, escalation continues. If 1 of the 3 patients experiences toxicity, an additional 3
patients are enrolled at the same dose. If none of these additional patients experiences
toxicity, escalation continues; however, if 1 patient has toxicity, the trial is stopped. If
2 or more have toxicities, the dose is de-escalated. If 2 or more of the original 3 patients
have toxicities, the dose is de-escalated. On day 15, patients are treated with sargramostim
(GM-CSF) intravenously over 4 hours if the bone marrow is free of residual leukemia; GM-CSF
treatment continues until the ANC is greater than 1,500/mm3 for 3 consecutive days.
PROJECTED ACCRUAL: For the pilot study of mitomycin C modulation of multidrug resistance
proteins, 12 patients will be accrued. For the phase I study of mitomycin C and mitoxantrone,
at least 17 patients will be entered.
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