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

Phase 2
16 Years
Not Enrolling
Extragonadal Germ Cell Tumor, Testicular Germ Cell Tumor

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Trial Information

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


- Determine the response rate (confirmed complete and partial responses) in men with
refractory testicular or extragonadal germ cell malignancies treated with arsenic

- 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

- 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

Inclusion Criteria


- 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

- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Tomasz M. Beer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

OHSU Knight Cancer Institute


United States: Federal Government

Study ID:




Start Date:

April 2002

Completion Date:

June 2007

Related Keywords:

  • Extragonadal Germ Cell Tumor
  • Testicular Germ Cell Tumor
  • recurrent malignant testicular germ cell tumor
  • extragonadal germ cell tumor
  • Neoplasms, Germ Cell and Embryonal



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