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
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.
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