Acute Myeloid Leukemia Clinical Trial
SJG-136 in Treating Patients With Relapsed or Refractory Acute Leukemia, Myelodysplastic Syndromes, Blastic Phase Chronic Myelogenous Leukemia, or Chronic Lymphocytic Leukemia
Summary
This phase I trial is studying the side effects and best dose of SJG-136 in treating patients with relapsed or refractory acute leukemia, myelodysplastic syndromes, blastic phase chronic myelogenous leukemia, or chronic lymphocytic leukemia. Drugs used in chemotherapy, such as SJG-136, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Full Description
OBJECTIVES:
I. Establish the maximum tolerated dose of SJG-136 in patients with relapsed or refractory acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) myelodysplastic syndrome (MDS), chronic myelogenous leukemia in blastic phase (CML-BP), or chronic lymphocytic leukemia (CLL).
II. Determine dose-limiting toxicities and pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive SJG-136 IV over 15 minutes on days 1-5. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of SJG-136 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 10 patients are treated at the MTD.
Eligibility Criteria
Inclusion Criteria:
Diagnosis of 1 of the following hematologic malignancies:
Acute myeloid leukemia
Acute lymphoblastic leukemia
Myelodysplastic syndromes
Chronic myelogenous leukemia in blastic phase
Chronic lymphocytic leukemia
Relapsed or refractory disease
No immediately available, potentially curable options (e.g., stem cell transplantation) available
Bilirubin normal (unless elevated due to Gilbert's syndrome)
HIV positivity allowed provided CD4 counts are normal with no AIDS-defining disease
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No uncontrolled intercurrent illness including, but not limited to, any of the following:
Ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Psychiatric illness or social situations that would limit study compliance
Recovered from prior therapy
ECOG performance status =< 2
SGOT and SGPT =< 2.5 times upper limit of normal (ULN)
Creatinine normal OR creatinine clearance >= 60 mL/min
Primary resistance (i.e., failed to achieve a complete remission [CR] to a standard induction regimen) or relapsed after achievement of a CR.
Must have documented failure to last cytotoxic regimen prior to study entry.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
No known CNS disease
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to SJG-136
More than 7 days since radiotherapy
No concurrent combination antiretroviral therapy for HIV-positive patients
No other anti-leukemia agents except hydroxyurea =< 5 grams/day =< 14 days prior to and during first course of treatment to control blood counts
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There is 1 Location for this study
Houston Texas, 77030, United States
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