A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Quarfloxin Administered Intravenously Weekly for Three Weeks of a Four Week Cycle in Patients With Advanced Solid Tumors or Lymphomas
- Patients with histologically confirmed solid tumors or lymphomas.
- Tumor progression after receiving standard/approved chemotherapy or where there is no
- One or more tumors measurable on radiograph or CT scan, or evaluable disease (e.g.,
- Karnofsky performance status of greater than or equal to 70.
- Life expectancy of at least 3 months.
- Age at least 18 years.
- Patients must have central IV access, or agree to the insertion of a central IV line.
- Normal oxygen saturation by pulse oximetry on room air
- A negative pregnancy test (if female).
- Acceptable liver function as evaluated by laboratory results
- Acceptable renal function as evaluated by laboratory results
- Acceptable hematologic status as evaluated by laboratory results
- No clinically significant urinalysis abnormalities
- Acceptable coagulation status as evaluated by laboratory results
- Fertile men and women must use effective contraceptive methods during the study.
- Seizure disorders requiring anticonvulsant therapy.
- Known brain metastases (unless previously treated and well controlled for a period of
greater than or equal to 3 months).
- Severe chronic obstructive pulmonary disease with hypoxemia, or an uncorrectable
- Major surgery, other than diagnostic surgery, within 4 weeks prior to the first dose
of test drug.
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic
- Pregnant or nursing women.
- Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy
within one month prior to study entry (6 weeks for nitrosoureas or Mitomycin C).
- Unwillingness or inability to comply with procedures required in this protocol.
- Known infection with HIV, hepatitis B, or hepatitis C.
- Clinically significant bleeding event within the last 3 months, unrelated to trauma,
or underlying condition that would be expected to result in a bleeding diathesis.
- Patients who are currently receiving any other investigational agent.
- Patients who have exhibited allergic reactions to a similar structural compound
(e.g., fluoroquinolones, biological agent or formulation.