17-DMAG in Treating Patients With Metastatic or Unresectable Solid Tumors or Lymphomas
Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
About this trial
This is an interventional treatment trial for Anaplastic Large Cell Lymphoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed solid tumor or lymphoma Metastatic or unresectable disease Standard curative or palliative measures do not exist or are no longer effective No known brain metastases Performance status - ECOG 0-2 Performance status - Karnofsky 60-100% More than 12 weeks Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9.0 g/dL ALT and AST ≤ 1.5 times upper limit of normal (ULN) Bilirubin ≤ normal Creatinine ≤ 1.25 times ULN Creatinine clearance ≥ 60 mL/min QTc < 450 msec for male patients (470 msec for female patients) LVEF > 40% by MUGA No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row) No myocardial infarction or active ischemic heart disease within the past year No New York Heart Association class III or IV congestive heart failure No poorly controlled angina No uncontrolled dysrhythmia requiring medication No left bundle branch block No history of congenital long QT syndrome No other significant cardiac disease Pulse oximetry at rest or on exercise > 88% No symptomatic pulmonary disease (e.g., chronic obstructive or restrictive pulmonary disease, etc.) or any of the following are allowed: Pulmonary disease requiring medication History of dyspnea, dyspnea on exertion, or paroxysmal nocturnal dyspnea Patients meeting the Medicare criteria for home oxygen or are on oxygen Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double barrier contraception 1 week before, during, and for at least 2 weeks after study participation No uncontrolled illness No active or ongoing infection No history of allergic reaction attributed to compounds of similar chemical or biological composition to 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) No psychiatric illness or social situation that would preclude study compliance No concurrent routine colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Concurrent hormonal therapy allowed At least 4 weeks since prior radiotherapy and recovered No prior radiation that included the heart in the field (e.g., mantle) No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent anticancer agents or therapies No concurrent medication that would prolong the QTc interval No other concurrent investigational agents
Sites / Locations
- University of Pittsburgh
Arms of the Study
Arm 1
Experimental
Treatment (alvespimycin hydrochloride)
Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) IV over 1-6 hours on days 1-3 or 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.