Metastatic Solid Tumors. Clinical Trial
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.
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.
| Status | Withdrawn |
| Enrollment | 100 |
| Est. completion date | September 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Hadassah Medical Organization | Jerusalem |
| Lead Sponsor | Collaborator |
|---|---|
| Hadassah Medical Organization | Novartis |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Evaluate the toxicity of Glivec in patients with solid tumors. |