Patient case: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

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.

Detailed 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: 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

Relevance to patient case: not relevant