Role of Glivec in Patients With Tumor Cells Positive for C-kit or PDGFR; a Multi Center Study.

This study has been withdrawn prior to enrollment.
(the PI is no longer work at Hadassah)
Sponsor:
Collaborator:
Novartis
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00159016
First received: September 8, 2005
Last updated: April 27, 2011
Last verified: September 2005
  Purpose

This is a phase II, multi-center (Israeli), open label, non-randomized trial for every patient with the specified tumors expressing c-kit or PDGFR. Expression of these kinases will be investigated in tumor samples obtained at the time of diagnosis or from the time of recurrent disease. Every patient with positive expression of either of the kinases will be evaluated for quantitative and qualitative evidence of disease prior to entry into the study, and if possible, no other treatment will be given concomitantly, to allow evaluation of the net effect of Glivec on tumor growth kinetics, searching for measurable evidence of response.

Glivec is supplied to the study investigators by Novartis Pharmaceutical. Patients will receive Glivec 400mg-800mg p.o./day for an exposure period of up to 12 months provided that in the opinion of the investigator the patient is benefiting from treatment with Glivec, and in the absence of any safety concern. For patients with brain tumors who are not receiving concomitant enzyme inducing anti-convulsant drugs, the recommended dose of Glivec is 800mg/day.


Condition Intervention Phase
Metastatic Solid Tumors.
Drug: Glivec
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Possible Role of Glivec in Patients With Tumor Cells Positive for C-kit or Platelet Derived Growth Factor Receptor (PDGFR); a Multi Center Study.

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Evaluate activity of Glivec in escalating doses 400 up to 800mg/day in patients with a large variety of metastatic solid tumors expressing c-kit or PDGFR.

Secondary Outcome Measures:
  • Evaluate the toxicity of Glivec in patients with solid tumors.

Estimated Enrollment: 100
Study Start Date: August 2002
Estimated Study Completion Date: September 2005
  Eligibility

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

Inclusion Criteria:

  • Patients > 18 years of age.
  • Histologically documented diagnosis of one of the specified tumors, which is malignant as well as unresectable and/or metastatic and therefore, incurable with any conventional multimodality approach and immunohistochemical documentation of c-kit (CD117) or PDGFR expression in the primary tumor or metastases by tumor (preferably on a tumor sample taken within 6 week of study entry).
  • At least one measurable site of disease as defined by Southwestern Oncology Group Solid Tumor Response Criteria.
  • Female patients of child-bearing potential must have negative pregnancy test.
  • Signed informed consent form.
  • Life expectancy >3 months.

Exclusion Criteria:

  • Patient has received any other investigational agents within 28 days of the first day of study drug dosing.
  • Existence of any evidence of another malignant disease, except superficial non-melanoma skin cancer.
  • Patient has a known brain metastases.
  • Patient previously received radiotherapy to >25% of the bone marrow.
  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: NCT00159016

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Novartis
Investigators
Principal Investigator: Shimon Slavin, MD Hadassah Medical Organization
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00159016     History of Changes
Other Study ID Numbers: 291004-HMO-CTIL
Study First Received: September 8, 2005
Last Updated: April 27, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014