A Randomized, Serum Level-targeted Study Investigating the Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Patients With Various Refractory Malignancies

Inclusion Criteria:

- Patients with hormone refractory prostate cancer, refractory multiple myeloma,
refractory bladder cancer, or malignant lymphoma;

- life expectancy of ≥6 months,

- Zubrod Performance Status of ≤2,

- adequate bone marrow function, renal function, liver function and pulmonary function;

- age ≥ 18 years;

- willing and able to give informed consent; and

- effective contraceptive use or non child-bearing potential.

Exclusion Criteria:

- 10% weight loss in the previous 3 months;

- active serious infection not controlled by antibiotics;

- initiation of bisphosphonates treatment within 30 days;

- participation in other research study within 30 days;

- uncontrolled brain metastasis,

- prior intrathecal chemotherapy or whole-brain radiotherapy,

- inability to comply with protocol or undergo specified tests;

- other active malignancy;

- optic neuritis, and

- routine use of diuretics (for initial phase of study only).