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Study of Temzolomide and Gleevec in Advanced Melanoma

Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Melanoma; Advanced Melanoma

Intervention: Gleevec + Temozolomide (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: University of Pennsylvania


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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To determine the safety and efficacy of combination therapy with Gleevec and Temzolomide in patients with advanced melanoma.

Secondary outcome: To evaluate the secondary endpoints of time to disease progression, duration of response, and overall survival of patients receiving Gleevec + Temozolomide


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Histologically confirmed melanoma that is metastatic or unresecatable 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

Locations and Contacts

Abramson Cancer Center at University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
Additional Information

Starting date: January 2003
Last updated: December 2, 2011

Page last updated: August 23, 2015

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