SJG-136 in Treating Patients With Relapsed or Refractory Acute Leukemia, Myelodysplastic Syndromes, Blastic Phase Chronic Myelogenous Leukemia, or Chronic Lymphocytic Leukemia

Stopped early · Phase 1

Conditions studied: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Blastic Phase Chronic Myelogenous Leukemia, de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Refractory Chronic Lymphocytic Leukemia, Relapsing Chronic Myelogenous Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes

In brief

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.

Key facts

Study ID

NCT00301769

Run by

National Cancer Institute (NCI)

People needed

25

Starts

2005-12-01

Last updated by the study team

2013-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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