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Study of Temzolomide and Gleevec in Advanced Melanoma

Primary Purpose

Melanoma, Advanced Melanoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gleevec
Temodar
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Temzolomide, Gleevec, Melanoma, Advanced melanoma, Phase II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Abramson Cancer Center at University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm A:

Arm Description

Temozolomide plus imatinib

Outcomes

Primary Outcome Measures

Safety - Grade 3 or 4 Adverse Events
Number of reported grade 3 or 4 adverse events

Secondary Outcome Measures

Response
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

Full Information

First Posted
April 24, 2008
Last Updated
March 7, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00667953
Brief Title
Study of Temzolomide and Gleevec in Advanced Melanoma
Official Title
Phase I/II Study of Temozolomide and Gleevec (Imatinib Mesylate, Formerly Known as STI571) in Advanced Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Difficulty enrolling subjects
Study Start Date
January 2003 (undefined)
Primary Completion Date
March 9, 2011 (Actual)
Study Completion Date
March 9, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Advanced Melanoma
Keywords
Temzolomide, Gleevec, Melanoma, Advanced melanoma, Phase II

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A:
Arm Type
Experimental
Arm Description
Temozolomide plus imatinib
Intervention Type
Drug
Intervention Name(s)
Gleevec
Other Intervention Name(s)
Imatinib mesylate
Intervention Description
Gleevec (600 mg) daily.
Intervention Type
Drug
Intervention Name(s)
Temodar
Other Intervention Name(s)
temozolomide
Intervention Description
Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle.
Primary Outcome Measure Information:
Title
Safety - Grade 3 or 4 Adverse Events
Description
Number of reported grade 3 or 4 adverse events
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Response
Description
Response rate by RECIST
Time Frame
through study completion, an average of 1 year
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Fecher, MD
Organizational Affiliation
Rogel Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
tara mitchell, MD
Organizational Affiliation
Abramson CC
Official's Role
Study Director
Facility Information:
Facility Name
Abramson Cancer Center at University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25252722
Citation
Bajor DL, Xu X, Torigian DA, Mick R, Garcia LR, Richman LP, Desmarais C, Nathanson KL, Schuchter LM, Kalos M, Vonderheide RH. Immune activation and a 9-year ongoing complete remission following CD40 antibody therapy and metastasectomy in a patient with metastatic melanoma. Cancer Immunol Res. 2014 Nov;2(11):1051-8. doi: 10.1158/2326-6066.CIR-14-0154. Epub 2014 Sep 24.
Results Reference
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Study of Temzolomide and Gleevec in Advanced Melanoma

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