Phase II Study Of Arsenic Trioxide In Patients With Refractory Germ Cell Malignancies

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