Study of Temzolomide and Gleevec in Advanced Melanoma

March 7, 2023 updated by: Abramson Cancer Center at Penn Medicine

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A:
Temozolomide plus imatinib
Drug: Gleevec
Gleevec (600 mg) daily.
Other Names:
  • Imatinib mesylate
Drug: Temodar
Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle.
Other Names:
  • temozolomide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - Grade 3 or 4 Adverse Events
Time Frame: through study completion, an average of 1 year
Number of reported grade 3 or 4 adverse events
through study completion, an average of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Collaborators

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

March 9, 2011

Study Completion (Actual)

March 9, 2011

Study Registration Dates

First Submitted

April 24, 2008

First Submitted That Met QC Criteria

April 25, 2008

First Posted (Estimate)

April 28, 2008

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 7, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 02602

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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