Status:
TERMINATED
SJG-136 in Treating Patients With Relapsed or Refractory Acute Leukemia, Myelodysplastic Syndromes, Blastic Phase Chronic Myelogenous Leukemia, or Chronic Lymphocytic Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 l...
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),...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00301769
Start Date
December 1 2005
Last Update
September 30 2013
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030