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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

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