VNP20009 in Treating Patients With Advanced Solid Tumors

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed advanced and/or metastatic solid tumors refractory to standard curative or palliative therapy and for which no other conventional therapy exists
• •Measurable or evaluable metastatic disease
• •No brain metastases unless previously treated and no evidence of recurrence
• •No lymphoma or other hematologic malignancy
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 and over
• •Performance status:
• •ECOG 0-1
• •Life expectancy:
• •At least 3 months
• •Hematopoietic:
• •Granulocyte count at least 2,000/mm\^3
• •Platelet count at least 100,000/mm\^3
• •Hematocrit at least 30% (transfusion allowed)
• •No known bleeding disorder
• •Hepatic:
• •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• •ALT and AST no greater than 1.5 times ULN (3 times ULN if liver metastases present)
• •Alkaline phosphatase no greater than 1.5 times ULN (3 times ULN if liver metastases present)
• •PT and PTT no greater than 1.5 times ULN
• •Hepatitis B surface antigen negative
• •No chronic active hepatitis B
• •No end-stage liver disease
• •Renal:
• •Creatinine no greater than 2.0 mg/dL
• •No urinary tract stones
• •No end-stage renal disease
• •Cardiovascular:
• •No known valvular disease
• •No known clinically significant atherosclerotic disease, peripheral vascular disease, or arterial aneurysm
• •No unstable angina
• •No artificial heart valves
• •Pulmonary:
• •No severe oxygen-dependent chronic obstructive pulmonary disease
• •Other:
• •No artificial implant that cannot be removed (e.g., prosthetic hips or knees or other devices)
• •No permanent central venous catheters
• •No gallstones
• •No active infection
• •No documented Salmonella infection
• •No tumor fever or fever of unknown origin or cause
• •Daily maximum temperature no greater than 38.0 degrees Celsius
• •HIV negative
• •No documented immunodeficiency
• •No other life-threatening illness
• •No history of allergic reaction or hypersensitivity to quinolone or cephalosporin antibiotics
• •No commercial food handlers, day-care workers, or health-care workers
• •No patients unable to avoid close personal contact with severely immunosuppressed individuals (e.g., other patients on myelosuppressive cancer chemotherapy)
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •At least 4 weeks since prior biologic therapy and recovered
• •Chemotherapy:
• •At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
• •Endocrine therapy:
• •At least 2 weeks since prior hormonal therapy and recovered
• •No concurrent steroids that could depress the immune system unless indicated for severe reactions
• •Radiotherapy:
• •At least 4 weeks since prior radiotherapy and recovered
• •Surgery:
• •At least 2 weeks since prior surgery and recovered
• •No prior splenectomy
• •No concurrent palliative surgery
• •Other:
• •Recovered from any other prior anticancer therapies
• •No concurrent antibiotics
• •No concurrent immunosuppressives or any other medications that could suppress the immune system
• •No other concurrent treatment for malignancy
• •No requirement for immediate palliative treatment