Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
Phase I and Pharmacodynamic Study of GTI-2040 (NSC 722929, IND 67368) in Acute Leukemias
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | City of Hope Medical Center | Duarte | California |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 28 days | Yes | |
Primary | Change in dCTP levels in PBMC and bone marrow by Real-Time PCR | Days 1, 4, 15, and 19 of course 1 | No | |
Secondary | Objective tumor response | Up to 3 years | No | |
Secondary | Overall survival | Up to 3 years | No | |
Secondary | Time to failure | Up to 3 years | No | |
Secondary | Duration of response | Up to 3 years | No | |
Secondary | Change in expression levels of R1, R2, and p53R2 mRNA in PBMC by Real-Time PCR | Day 1, 4, 15, and 19 of course 1 | No | |
Secondary | Change in intracellular levels of GTI-2040 by ELISA | Day 1, 4, 15, and 19 of course 1 | No | |
Secondary | Incidence of grade 3 or higher toxicity assessed by CTCAE v3.0 | Up to 3 years | Yes |
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