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
Completed · Phase 1
Conditions studied: Acute Undifferentiated Leukemia, 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, Relapsing Chronic Myelogenous Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Untreated Adult Acute Lymphoblastic Leukemia, Untreated Adult Acute Myeloid Leukemia
In brief
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 refractory or blastic phase chronic myelogenous leukemia. Drugs used in chemotherapy, such as GTI-2040, work in different ways to stop the growth of cancer or abnormal cells, either by killing the cells or by stopping them from dividing.
Key facts
- Study ID
- NCT00459212
- Run by
- National Cancer Institute (NCI)
- People needed
- 24
- Starts
- 2007-03-01
- Last updated by the study team
- 2015-12-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- City of Hope Medical Center — Duarte, California, United States
Full record on ClinicalTrials.gov
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