Protein Tyrosine Kinases (PTK) in Multiple Myeloma
This study has been completed.
Sponsor:
Dana-Farber Cancer Institute
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
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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) |
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
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 May 23, 2013