Arsenic Trioxide in Treating Men With Germ Cell Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00036842
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 24, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

May 13, 2002
January 27, 2003
June 24, 2013
April 2002
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Complete list of historical versions of study NCT00036842 on Archive Site
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Arsenic Trioxide in Treating Men With Germ Cell Cancer
Phase II Study Of Arsenic Trioxide In Patients With Refractory Germ Cell Malignancies

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.


  • 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.

Phase 2
Primary Purpose: Treatment
  • Extragonadal Germ Cell Tumor
  • Testicular Germ Cell Tumor
Drug: arsenic trioxide
Not Provided
Beer TM, Tangen CM, Nichols CR, Margolin KA, Dreicer R, Stephenson WT, Quinn DI, Raghavan D, Crawford ED. Southwest Oncology Group phase II study of arsenic trioxide in patients with refractory germ cell malignancies. Cancer. 2006 Jun 15;106(12):2624-9.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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June 2007
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  • 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



  • 16 and over


  • Male

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified


  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • WBC at least 3,000/mm^3


  • Bilirubin less than 2.5 times upper limit of normal (ULN)
  • SGOT less than 5 times ULN
  • Alkaline phosphatase less than 5 times ULN


  • Creatinine no greater than 2.5 times ULN OR
  • Creatinine clearance at least 40 mL/min
  • Potassium normal
  • Magnesium normal
  • No renal dialysis


  • 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


  • 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


Biologic therapy:

  • See Disease Characteristics


  • See Disease Characteristics
  • More than 28 days since prior cytotoxic agents

Endocrine therapy:

  • Not specified


  • See Disease Characteristics
  • At least 28 days since prior radiotherapy and recovered


  • Not specified


  • More than 28 days since prior experimental agents
  • No concurrent or planned drugs known to prolong the QT interval
Sexes Eligible for Study: Male
16 Years and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Tomasz M. Beer, MD OHSU Knight Cancer Institute
National Cancer Institute (NCI)
August 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP