Status:
TERMINATED
Study of Temzolomide and Gleevec in Advanced Melanoma
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Melanoma
Advanced Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study has been designed to evaluate the side effects of Gleevec when given in combination with Temzolomide; and to learn more about how these drugs work in the body and whether this combination i...
Eligibility Criteria
Inclusion
- Histologically confirmed melanoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
- Prior chemotherapy, immunotherapy, radiation therapy (Phase I portion only), cytokine, biologic, or vaccine therapy is permitted, however no prior treatment with temozolomide
- Measurable disease
- Performance status \<= 2
- Life expectancy greater than 3 months
Exclusion
- No prior treatment with temozolomide or imatinib mesylate
- Organ allografts
- Prior radiotherapy, or prior intratumor injection therapy, to areas of measurable disease that are used as target indicator lesions, unless progression has occurred at that site or measurable disease has developed outside the treatment area
- Pregnancy or lactation
- History of second cancer
- Known hypersensitivity to temozolomide or imatinib
- Use of any experimental therapy within 3 weeks prior to baseline evaluations done prior to enrollment
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00667953
Start Date
January 1 2003
End Date
March 9 2011
Last Update
March 30 2023
Active Locations (1)
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1
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104