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

Stopped early · Phase 1/Phase 2

Conditions studied: Prostatic Neoplasms, Multiple Myeloma, Bladder Neoplasms, Lymphoma

In brief

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.

Key facts

Study ID

NCT00050687

Run by

Titan Pharmaceuticals

Starts

2001-06-01

Expected to finish

2005-03-01

Last updated by the study team

2011-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Highlands Oncology Group, PA — Springdale, Arkansas, United States
• California Cancer Care — Greenbrae, California, United States
• Stanford University — Palo Alto, California, United States
• Southfield Oncology Institute — Southfield, Michigan, United States
• New York Presbyterian Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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