Arsenic Trioxide in Treating Men With Germ Cell Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Extragonadal Germ Cell Tumor, Testicular Germ Cell Tumor

Intervention / Treatment
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* Drug: arsenic trioxide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: arsenic trioxide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent malignant testicular germ cell tumor, extragonadal germ cell tumor