Study of Temzolomide and Gleevec in Advanced Melanoma

Phase 1

Terminated

• Conditions: Melanoma; Advanced Melanoma
• Interventions: Drug: Gleevec; Drug: Temodar

• Registration Number: NCT00667953
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2008-04-24
• Study First Submitted QC: 2008-04-25
• Study First Posted: 2008-04-28
• Primary Completion: 2011-03-09
• Study Completion: 2011-03-09
• Disposition First Submitted: 2020-04-06
• Disposition First Submitted QC: 2020-04-06
• Disposition First Posted: 2020-04-09
• Results First Submitted: 2021-08-25
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-07
• Last Update Submitted: 2023-03-07
• Results First Posted: 2023-03-30
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A:	Gleevec	Temozolomide plus imatinib
Arm A:	Temodar	Temozolomide plus imatinib

Primary Outcome Measures

Name	Time	Method
Safety - Grade 3 or 4 Adverse Events	through study completion, an average of 1 year	Number of reported grade 3 or 4 adverse events

Secondary Outcome Measures

Name	Time	Method
Response	through study completion, an average of 1 year	Response rate by RECIST
To Evaluate the Secondary Endpoints of Time to Disease Progression, Duration of Response, and Overall Survival of Patients Receiving Gleevec + Temozolomide	through study completion

Trial Locations

Locations (1)

Abramson Cancer Center at University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States