Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Various Refractory Malignancies

• Status: Terminated
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will test the safety, tolerance, and efficacy of different doses of oral gallium maltolate. Patients will receive oral gallium maltolate twice daily for 28-consecutive days followed by 14 days off treatment. This dosing cycle will be repeated. Adverse effects will be assessed and the levels of gallium in serum will be measured. Any effect of the drug on the cancer and any improvement in cancer-related symptoms will also be measured.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Titan Pharmaceuticals

Criteria

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).