SWOG clinical trial number
S0207
Phase II Study of Arsenic Trioxide in Male Patients with Refractory Germ Cell Malignancies
Closed
Phase
Accrual
50%
Published
Research committees
Genitourinary Cancer
Treatment
Arsenic Trioxide
Surgery
Eligibility Criteria Expand/Collapse
Pt must be male w/prior hist conf of testicular or extragonadal germ cell neoplasm. Pt must have refractory dx as defined in Section 5.2 and one or more of the criteria in Section 5.3. Non-meas dx must be assessed w/in 42 days of reg. Pt must not have had tx w/cytotoxic or experimental agents w/in 28 days prior to reg. Pt may have rec'd prior RT. Pt must not have active, serious, uncontrolled infections. Pt must not have a known hypersensitivity to arsenic. Pt must not be rec'g or planning to receive drugs known to prolong the QT interval. Pts must not have a hx of torsades de pointes type ventricular arrhythmia. Pt must not have a prolonged QT interval > 450 msec on ECG. Pt must have AGC >/= 1500, PLT >/= 100,000, WBC >/= 3000; creatinine < /= 2.5 X IULN or measured Cr Cl > /= 40 ml/min; Bili < 2.5 x IULN or SGOT or Alk Phos < 5 x IULN; K and Mg w/in institutional range of normal; LDH obtained w/in 28 days prior to reg. Pt must have Zubrod PS </= 2. Pts must be > /= 16 yrs. Pt must have no other prior malignancy and have agreed to use an effective contraceptive method.
Publication Information Expand/Collapse
2006
Southwest Oncology Group phase II study of arsenic trioxide in patients with refractory germ cell malignancies
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Phase
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Phase
SWOG Clinical Trial Number
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Research Committee(s)
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Activated
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Accrual
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Open
Phase