Clinical trial NCT00036842 (phase 2, status: completed)
Conditions: extragonadal germ cell tumor, testicular germ cell tumor
ICD codes: E29.0, E29.1, E29.8, E29.9, E89.5, N50.811, N50.812
Drugs: arsenic trioxide
SMILES: O=[As]O[As]=O
Eligibility 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:

          -  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