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

Brief Title

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

Official Title

A Phase I Study of SJG-136 in Patients With Advanced Leukemia

Brief 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.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Maximum tolerated dose (MTD) determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)

Condition

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Intervention

SJG-136

Study Arms / Comparison Groups

 Arm I

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

25

Start Date

December 2005

Primary Completion Date

February 2009

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Farhad Ravandi-Kashani, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT00301769

Organization ID

NCI-2009-00100

Secondary IDs

NCI-2009-00100

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)

Study Sponsor

Farhad Ravandi-Kashani, Principal Investigator, M.D. Anderson Cancer Center

Verification Date

September 2013