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Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Various Refractory Malignancies
This study has been terminated.
Sponsored by: Titan Pharmaceuticals
Information provided by: Titan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00050687
  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 I
Phase II

Genetics Home Reference related topics: aceruloplasminemia bladder cancer hemophilia
MedlinePlus related topics: Bladder Cancer Cancer Lymphoma Multiple Myeloma Prostate Cancer
Drug Information available for: Gallium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: A Randomized, Serum Level-Targeted Study Investigating the Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Patients With Various Refractory Malignancies

Further study details as provided by Titan Pharmaceuticals:

Study Start Date: June 2001
Estimated Study Completion Date: February 2005
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
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
Stanford University
Palo Alto, California, United States, 94303
California Cancer Care
Greenbrae, California, United States, 94904
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

Study ID Numbers: TTP-370-01-01
Study First Received: December 17, 2002
Last Updated: August 19, 2008
ClinicalTrials.gov Identifier: NCT00050687  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Genital Neoplasms, Male
Prostatic Diseases
Blood Protein Disorders
Urogenital Neoplasms
Paraproteinemias
Urologic Neoplasms
Hemostatic Disorders
Hemorrhagic Disorders
Urologic Diseases
Multiple myeloma
Lymphoma
Bladder neoplasm
Immunoproliferative Disorders
Cystocele
Hematologic Diseases
Blood Coagulation Disorders
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Vascular Diseases
Genital Diseases, Male
Multiple Myeloma
Lymphatic Diseases
Lymphoproliferative Disorders
Prostatic Neoplasms
Urinary tract neoplasm
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009