Arsenic Trioxide in Treating Men With Germ Cell Cancer

SWOG Cancer Research Network

Status and phase

Completed

Phase 2

Conditions

Extragonadal Germ Cell Tumor

Testicular Germ Cell Tumor

Treatments

Drug: arsenic trioxide

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00036842

SWOG-S0207

CDR0000069328

Details and patient eligibility

About

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.

Full description

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.

Sex

Male

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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: