Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Arsenic Trioxide in Treating Men With Germ Cell Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	16 and over	NCI	SWOG-S0207 S0207, NCT00036842

Objectives

1. Determine the response rate (confirmed complete and partial responses) in men with refractory testicular or extragonadal germ cell malignancies treated with arsenic trioxide.
2. Determine the overall and progression-free survival of patients treated with this drug.
3. Determine the qualitative and quantitative toxic effects of this drug in these patients.
4. Assess the biomarker response rate in patients with elevated biomarkers treated with this drug.

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³
• WBC at least 3,000/mm³

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

Expected Enrollment

A total of 20-40 patients will be accrued for this study within 10-40 months.

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.

Beer TM, Tangen CM, Nichols CR, et al.: Southwest Oncology Group phase II study of arsenic trioxide in patients with refractory germ cell malignancies. Cancer 106 (12): 2624-9, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Tomasz Beer, MD, Protocol chair		Ph: 503-494-0365; 800-494-1234

Registry Information
Official Title		Phase II Study Of Arsenic Trioxide In Patients With Refractory Germ Cell Malignancies
Trial Start Date		2002-04-29
Registered in ClinicalTrials.gov		NCT00036842
Date Submitted to PDQ		2002-03-08
Information Last Verified		2004-08-26
NCI Grant/Contract Number		CA32102

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