Study of Temzolomide and Gleevec in Advanced Melanoma



Status:Completed
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/31/2018
Start Date:January 2003

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Phase I/II Study of Temozolomide and Gleevec (Imatinib Mesylate, Formerly Known as STI571) in Advanced Melanoma

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 is useful in treating patients with melanoma.


Inclusion Criteria:

- 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

- ECOG performance status <= 2

- Life expectancy greater than 3 months

Exclusion Criteria:

- 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
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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mi
from
Philadelphia, PA
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