Status:
COMPLETED
AT7519M in Treating Patients With Advanced or Metastatic Solid Tumors or Refractory Non-Hodgkin's Lymphoma
Lead Sponsor:
NCIC Clinical Trials Group
Conditions:
Lymphoma
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 tre...
Detailed Description
OBJECTIVES: Primary * Determine the recommended phase II dose of AT7519M in patients with advanced or metastatic solid tumors or refractory non-Hodgkin's lymphoma. * Determine the safety, tolerabili...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 5 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2013
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00390117
Start Date
January 5 2007
End Date
January 10 2013
Last Update
August 4 2023
Active Locations (2)
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1
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
2
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9