Phase I Dose Escalation Study to Evaluate the Safety of T138067-Sodium in Patients With Advanced Refractory Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced refractory cancer Must meet one
of the following criteria: - Failed at least 1 regimen of radiotherapy, chemotherapy, or
immunotherapy and not a candidate for a regimen of higher efficacy - Refractory to
existing standard therapy and not candidate for a regimen of higher efficacy - Advanced
malignancy for which there is no standard chemotherapy available No known brain metastases
or leptomeningeal involvement

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Greater than 3 months Hematopoietic: Absolute neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 Prothrombin time at least 30% of control
Partial thromboplastin time at least 30% of control Hepatic: Bilirubin less than 2 mg/dL
ALT and AST no greater than 2 times normal Alkaline phosphatase no greater than 2 times
normal Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min
Cardiovascular: No New York Heart Association class III or IV heart disease No myocardial
infarction in the past 6 months Other: No immunodeficiency syndrome (acquired or
congenital) No uncontrolled infection No significant comorbidity that may compromise
participation in this study Not pregnant Effective contraception required of all fertile
patients during and until 3 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 4 weeks
since prior immunotherapy No concurrent immunotherapy or biologic response modifier
therapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior
chemotherapy No concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids
Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No
concurrent radiotherapy Surgery: At least 3 weeks since any prior major surgery Other: No
organ allograft At least 30 days since any prior investigational agents No concurrent
nonsteroidal antiinflammatory agents or aspirin No concurrent alternative therapies (i.e.,
herbal medicines, high doses of vitamins) No other concurrent investigational agents