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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

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