AT7519M in Treating Patients With Advanced or Metastatic Solid Tumors or Refractory Non-Hodgkin's Lymphoma
Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring unspecified adult solid tumor, protocol specific, recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, Waldenstrom macroglobulinemia, recurrent adult grade III lymphomatoid granulomatosis, adult nasal type extranodal NK/T-cell lymphoma, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma
Eligibility 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
Sites / Locations
- Juravinski Cancer Centre at Hamilton Health Sciences
- Univ. Health Network-Princess Margaret Hospital
Arms of the Study
Arm 1
Experimental
CDKI AT7519
AT7519M (1 hour IV) on days 1, 4, 8 and 11 every 5 weeks.