Extragonadal Germ Cell Tumor, Testicular Germ Cell Tumor
Conditions
Keywords
recurrent malignant testicular germ cell tumor, extragonadal germ cell tumor
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating men who have germ cell cancer that has not responded to previous treatment.
Detailed description
OBJECTIVES: * Determine the response rate (confirmed complete and partial responses) in men with refractory testicular or extragonadal germ cell malignancies treated with arsenic trioxide. * Determine the overall and progression-free survival of patients treated with this drug. * Determine the qualitative and quantitative toxic effects of this drug in these patients. * Assess the biomarker response rate in patients with elevated biomarkers treated with this drug. OUTLINE: This is a multicenter study. Patients receive arsenic trioxide IV over 1-2 hours on days 1-5. Courses repeat every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity. Patients who achieve a confirmed complete or partial response receive up to 3 additional courses past response. Patients are followed every 2 months for 3 years or until disease progression. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 10-40 months.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed testicular or extragonadal germ cell cancer * Refractory disease, defined by at least 1 of the following criteria: * Disease progression during or within 4 weeks of cisplatin-containing regimen * Progression is defined as the appearance of new or progression of known locally advanced or metastatic disease or a rise in tumor markers (beta-human chorionic gonadotropin (beta-HCG) or alpha fetoprotein (AFP)) by at least 50% relative to the nadir * When the only evidence of germ cell progression or recurrence before study entry is the appearance of a new lesion in the absence of tumor marker elevation, a biopsy is required to confirm the diagnosis * Disease recurrence after at least 2 chemotherapy regimens, one of which includes high-dose therapy (chemotherapy with stem cell support) * Disease recurrence after at least 2 chemotherapy regimens and not eligible for high-dose therapy * At least 1 of the following: * Unidimensionally measurable disease * Soft tissue, irradiated within the past 2 months, is not considered measurable * Elevated beta-HCG (more than 20 mIU/mL) * AFP greater than 2 times upper limit of normal PATIENT CHARACTERISTICS: Age: * 16 and over Sex: * Male Performance status: * Zubrod 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * WBC at least 3,000/mm\^3 Hepatic: * Bilirubin less than 2.5 times upper limit of normal (ULN) * SGOT less than 5 times ULN * Alkaline phosphatase less than 5 times ULN Renal: * Creatinine no greater than 2.5 times ULN OR * Creatinine clearance at least 40 mL/min * Potassium normal * Magnesium normal * No renal dialysis Cardiovascular: * No prior torsades de pointes-type ventricular arrhythmia * No prolonged QT interval (greater than 450 msec) on ECG in presence of normal potassium and magnesium Other: * Fertile patients must use effective contraception * No active serious infection not controlled by antibiotics * No known hypersensitivity to arsenic * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II disease in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics * More than 28 days since prior cytotoxic agents Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 28 days since prior radiotherapy and recovered Surgery: * Not specified Other: * More than 28 days since prior experimental agents * No concurrent or planned drugs known to prolong the QT interval
Countries
United States