Arsenic Trioxide in Treating Men With Germ Cell Cancer

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Arsenic Trioxide

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