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Protein Tyrosine Kinases (PTK) in Multiple Myeloma

This study has been completed.

Sponsors and Collaborators: Dana-Farber Cancer Institute
Brigham and Women's Hospital
Novartis
Information provided by: Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00165347
  Purpose

The purpose of this study is to determine whether or not cancer cells in the body are affected by PTK and whether it affects the growth of these cells.


Condition Intervention Phase
Multiple Myeloma
Drug: PTK787/ZK222584
Phase II

Genetics Home Reference related topics:   aceruloplasminemia    hemophilia   

MedlinePlus related topics:   Cancer    Multiple Myeloma   

Drug Information available for:   Vatalanib    Butanedioic acid, compd. with N-(4-chlorophenyl)-4-(4-pyridinylmethyl)-1-phthalazinamine (1:1)    Tyrosine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   Phase II Study of PTK787/ZK222584 in Multiple Myeloma

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine the effectiveness of PTK in treating patients with relapsed or refractory myeloma

Secondary Outcome Measures:
  • To evaluate the progression free survival of patients treated with PTK
  • to investigate the safety of PTK in patients with relapsed/refractory multiple myeloma

Estimated Enrollment:   10
Study Start Date:   December 2003
Study Completion Date:   October 2006
Primary Completion Date:   October 2006 (Final data collection date for primary outcome measure)

Detailed Description:

Patients will take PTK orally once a day for the duration of their time on the study. Each cycle of chemotherapy will last for 4 weeks.

Measurement of vital signs will be done weekly during the first month of treatment.

Physical exam, vital signs, blood work, a quality of life assessment, and x-ray or MRI wil be performed every 4 weeks.

Patients will remain on the study until their disease fails to respond to treatment or there are intolerable side effects. Typically treatment is performed for 12 weeks and up to one year in patients that are stable and responding.

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

Criteria

Inclusion Criteria:

  • Older than 18 years of age.
  • Confirmed diagnosis of active progressive multiple myeloma
  • History of > 2 prior cytotoxic treatment regimens. Bone marrow transplantation will be considered as one regimen.
  • Current measurable disease based on serum and/or urine M protein and/or measurable plasmacytoma.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Absolute neutrophil count (ANC) > 1,500 mm3
  • Platelets > 100,000 mm3
  • Serum creatinine < 1.5 upper limit of normal (ULN)
  • Serum bilirubin < 1.5 ULN
  • AST/AGOT and ALT/SGPT < 3.0 ULN
  • Life expectancy > 12 weeks

Exclusion Criteria:

  • Chemotherapy < 3 weeks prior to registration.
  • Biologic or immunotherapy < 2 weeks prior to registration
  • Full field radiotherapy < 4 weeks or limited field radiotherapy < 2 weeks prior to registration.
  • History or presence of central nervous system (CNS) disease
  • History of leukemia
  • History of another primary malignancy with the exception of inactive basal or squamous cell carcinoma of the skin
  • Major surgery < 4 weeks prior to registration
  • Prior therapy with anti-vascular endothelial growth factor (VEGF) agents excluding thalidomide, Revimid, velcade and arsenic trioxide
  • Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
  • Pleural effusion or ascites that cause respiratory compromise
  • Female patients that are pregnant or breast feeding
  • Uncontrolled high blood pressure, history of labile hypertension or history of poor compliance with an antihypertensive regimen
  • Unstable angina pectoris
  • Symptomatic congestive heart failure
  • Myocardial infarction < 6 months prior to registration
  • Serious uncontrolled cardiac arrhythmia
  • Uncontrolled diabetes
  • Active or uncontrolled infection
  • Acute or chronic liver disease
  • Impairment of gastrointestinal (GI) function or GI disease
  • Confirmed HIV infection
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165347

Locations
United States, Massachusetts
Dana-Farber Cancer Institute    
      Boston, Massachusetts, United States, 02115

Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Novartis

Investigators
Principal Investigator:     Nikhil Munshi, MD     Dana-Farber Cancer Institute    
  More Information


Study ID Numbers:   03-257
First Received:   September 9, 2005
Last Updated:   December 20, 2007
ClinicalTrials.gov Identifier:   NCT00165347
Health Authority:   United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Multiple myeloma  
PTK  
Relapsed multiple myeloma  
Refractory Multiple myeloma  
Myeloma  

Study placed in the following topic categories:
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Vatalanib
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Enzyme Inhibitors
Cardiovascular Diseases
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2008




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