Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Various Refractory Malignancies - Full Text View

Purpose

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.

Condition	Intervention	Phase
Prostatic Neoplasms Multiple Myeloma Bladder Neoplasms Lymphoma	Drug: Gallium maltolate	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Serum Level-targeted Study Investigating the Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Patients With Various Refractory Malignancies

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Cancer

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Multiple Myeloma

U.S. FDA Resources

Further study details as provided by Titan Pharmaceuticals:


Study Start Date:	June 2001
Study Completion Date:	March 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Detailed Description:

Gallium maltolate is an orally bioavailable form of gallium. This is a safety, pharmacokinetic and preliminary efficacy study. The primary objective of the study is to assess the safety profile in patients after oral administration of different doses of gallium maltolate for up to six 42-day cycles (28 days of gallium maltolate, followed by 14 days off treatment). In addition, serum concentrations of gallium and associated pharmacokinetic variables will be measured. From this information, an optimal dose will be selected for assessment of anti-tumor efficacy. The study assesses the effects of oral administration of gallium maltolate on pain resulting from bony metastasis, on biochemical measures of bone turnover, and on disease progression and overall survival in patients with various refractory malignancies. Patients may receive up to 6 cycles of the investigational agent.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050687

Locations


United States, Arkansas
Highlands Oncology Group, PA
Springdale, Arkansas, United States, 72764
United States, California
California Cancer Care
Greenbrae, California, United States, 94904
Stanford University
Palo Alto, California, United States, 94303
United States, Michigan
Southfield Oncology Institute
Southfield, Michigan, United States, 48076
United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10021

Sponsors and Collaborators

Titan Pharmaceuticals

More Information

No publications provided


ClinicalTrials.gov Identifier:	NCT00050687 History of Changes
Other Study ID Numbers:	TTP-370-01-01
Study First Received:	December 17, 2002
Last Updated:	January 21, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Neoplasms Prostatic Neoplasms Genital Diseases, Male Genital Neoplasms, Male	Neoplasms by Site Prostatic Diseases Urogenital Neoplasms

ClinicalTrials.gov processed this record on February 27, 2015