AT7519M in Treating Patients With Advanced or Metastatic Solid Tumors or Refractory Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2013-01-10
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: AT7519M may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of AT7519M in treating patients with advanced or metastatic solid tumors or refractory non-Hodgkin's lymphoma.

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

Details

• Lead Sponsor: NCIC Clinical Trials Group

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed diagnosis of 1 of the following:

• Advanced and/or metastatic solid tumor

• No more than 3 prior regimens for metastatic disease

• Refractory non-Hodgkin's lymphoma

• Clinically or radiologically documented disease

• Patients whose only evidence of disease is tumor marker elevation are not eligible

• No untreated brain or meningeal metastases

• Patients with radiologic or clinical evidence of stable, treated brain metastases are eligible provided they are asymptomatic AND have no requirement for corticosteroids

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Absolute granulocyte count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Creatinine ≤ 1.25 times upper limit of normal (ULN) OR creatinine clearance ≥ 50 mL/min

• Bilirubin normal

• ALT and AST ≤ 2 times ULN (5 times ULN if patient has documented liver metastases)

• Potassium normal

• Calcium normal

• Creatine kinase (CK or CPK) ≤ 2 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No pre-existing cardiovascular conditions and/or symptomatic cardiac dysfunction, including any of the following:

• Significant cardiac event (including symptomatic heart failure or angina) within the past 3 months or any cardiac disease that, in the opinion of the investigator, increases the risk for ventricular arrhythmia

• Any history of ventricular arrhythmia, which was symptomatic or required treatment (CTC grade 3), including multifocal PVCs, bigeminy, trigeminy, or ventricular tachycardia

• Uncontrolled hypertension

• Previous history of QT prolongation with other medication

• Congenital long QT syndrome

• QT and QTc, with Bazett's correction, unmeasurable or ≥ 460 msec on screening ECG

• LVEF < 45 % by MUGA for patients with significant cardiac history (i.e., myocardial infarction, severe hypertension, or arrhythmia) or prior doxorubicin (> 450 mg/m²)

• No active or uncontrolled infections

• No serious illness or medical condition that would preclude study compliance

• No peripheral neuropathy > grade 1

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 21 days since prior cytotoxic chemotherapy and recovered (solid tumors)

• At least 21 days since prior palliative radiotherapy and recovered

• Exceptions may be made for low-dose, nonmyelosuppressive radiotherapy

• Prior hormonal, immunologic, biologic, or signal transduction inhibitor therapy allowed

• At least 14 days since prior major surgery and recovered (no nonhealing wounds)

• At least 4 weeks since prior steroids

• No other concurrent medications which affect QT/QTc and cannot be discontinued

• No other concurrent experimental drugs or anticancer therapy