Multiple Myeloma Clinical Trial
Official title:
A Randomized, Serum Level-targeted Study Investigating the Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Patients With Various Refractory Malignancies
Verified date | November 2006 |
Source | Titan Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 0 |
Est. completion date | March 2005 |
Est. primary completion date | March 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | California Cancer Care | Greenbrae | California |
United States | New York Presbyterian Hospital | New York | New York |
United States | Stanford University | Palo Alto | California |
United States | Southfield Oncology Institute | Southfield | Michigan |
United States | Highlands Oncology Group, PA | Springdale | Arkansas |
Lead Sponsor | Collaborator |
---|---|
Titan Pharmaceuticals |
United States,
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