Protein Tyrosine Kinases (PTK) in Multiple Myeloma

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Novartis
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00165347
First received: September 9, 2005
Last updated: December 20, 2007
Last verified: December 2007
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of PTK787/ZK222584 in Multiple Myeloma

Resource links provided by NLM:


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
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: 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

No publications provided

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

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

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Vatalanib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014