NCT00036842
Arsenic Trioxide in Treating Men With Germ Cell Cancer
PHASE2
COMPLETED
NCT00036842
INTERVENTIONAL
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.
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
Extragonadal Germ Cell Tumor
Testicular Germ Cell Tumor
- TREATMENT
-
- Type: DRUG
- Name: arsenic trioxide
- Description:
- Arm Group Labels:
- SWOG Cancer Research Network