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

NCT ID: NCT00159016

Last Updated: 2011-04-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31
• Study Completion Date: 2005-09-30

Brief Summary

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.

Conditions

Metastatic Solid Tumors.

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Glivec

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Principal Investigators

Shimon Slavin, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Hadassah Medical Organization

Jerusalem, , Israel

Countries

Israel

Other Identifiers

291004-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id