Arsenic Trioxide in Treating Men With Germ Cell Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00036842
First received: May 13, 2002
Last updated: June 21, 2013
Last verified: August 2004

May 13, 2002
June 21, 2013
April 2002
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Complete list of historical versions of study NCT00036842 on ClinicalTrials.gov 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.

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.

Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
June 2007
Not Provided

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
Male
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00036842
CDR0000069328, SWOG-S0207
Not Provided
Not Provided
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