Status:
COMPLETED
GTI-2040 in Treating Patients With Relapsed, Refractory, or High-Risk Acute Leukemia, High-Grade Myelodysplastic Syndromes, or Refractory or Blastic Phase Chronic Myelogenous Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Acute Undifferentiated Leukemia
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of GTI-2040 in treating patients with relapsed, refractory, or high-risk acute leukemia, high-grade myelodysplastic syndromes, or refracto...
Detailed Description
OBJECTIVES: I. Determine the maximum tolerated dose of GTI-2040 in patients with relapsed, refractory, or high-risk acute leukemia, high-grade myelodysplastic syndromes, or refractory or blastic phas...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Diagnosis of 1 of the following:
- Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) refractory to primary standard induction therapy
- Relapsed or refractory acute leukemia
- Chronic myelogenous leukemia (CML) in blast crisis at diagnosis OR that failed prior aggressive induction chemotherapy
- Diagnosis of 1 of the following:
- Acute leukemia secondary to preexisting hematologic condition or prior chemotherapy at diagnosis OR that failed prior aggressive induction chemotherapy
- Advanced myelodysplastic syndromes (intermediate-1 or greater)
- De novo acute leukemia (myeloid or nonmyeloid)
- Not a candidate for aggressive standard induction chemotherapy
- De novo AML or ALL (patients \> 60 years of age)
- No suspected or proven active CNS leukemia
- ECOG performance status (PS) 0-2 OR Karnofsky PS 50-100%
- Life expectancy \>= 8 weeks
- Bilirubin =\< 1.5 mg/dL
- AST and ALT \< 3 times upper limit of normal (ULN)
- Creatinine =\< 1.5 times ULN
- No HIV positivity
- Fertile patients must use effective contraception
- No history of allergic reactions attributed to other phosphorothiolated oligonucleotides
- No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing, active, or poorly controlled infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Cardiac arrhythmia
- Poorly controlled pulmonary disease
- Psychiatric illness or social situation that would preclude study compliance
- Recovered from all prior therapies
- Prior autologous or allogeneic stem cell transplantation allowed (No active graft-vs-host disease \> grade 2)
- At least 2 weeks since prior and no concurrent cytotoxic chemotherapy
- At least 2 weeks since prior and no concurrent biologic therapy
- At least 2 weeks since any other prior investigational agent
- No other concurrent anticancer therapy, including radiotherapy or hormonal therapy
- Concurrent imatinib mesylate for CML allowed
- Not pregnant or nursing
- Negative pregancy test
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00459212
Start Date
March 1 2007
Last Update
December 4 2015
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010