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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I

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.

Group Type EXPERIMENTAL

SJG-136

Intervention Type DRUG

Given IV

Interventions

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SJG-136

Given IV

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Farhad Ravandi-Kashani

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States