A Phase I Study Of 17-Dimethylaminoethylamino-17-Demethoxygeldanamycin, (17-DMAG) (NSC 707545) In Patients With Advanced Solid Tumors

Date de début de l'étude : 1 juillet 2004

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