Study of Temzolomide and Gleevec in Advanced Melanoma

Sponsor

Abramson Cancer Center of the University of Pennsylvania (Other)

Overall Status

Terminated

CT.gov ID

NCT00667953

Collaborator

Novartis Pharmaceuticals (Industry)

Enrollment

Location

Arm

98.2

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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 is useful in treating patients with melanoma.

Condition or Disease	Intervention/Treatment	Phase
Melanoma Advanced Melanoma	Drug: Gleevec + Temozolomide	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2003

Actual Primary Completion Date :

Mar 9, 2011

Actual Study Completion Date :

Mar 9, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A:	Drug: Gleevec + Temozolomide Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle. Gleevec (600 mg) daily. Other Names: Imatinib mesylate temodar

Arm

Intervention/Treatment

Experimental: Arm A:

Drug: Gleevec + Temozolomide

Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle. Gleevec (600 mg) daily.

Other Names:

Imatinib mesylate

temodar

Outcome Measures

Primary Outcome Measures

To determine the safety and efficacy of combination therapy with Gleevec and Temzolomide in patients with advanced melanoma. [Interim analysis after accrual of 17 patients]

Secondary Outcome Measures

To evaluate the secondary endpoints of time to disease progression, duration of response, and overall survival of patients receiving Gleevec + Temozolomide [Interim analysis after accruing 17 patients]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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