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Study of Temzolomide and Gleevec in Advanced Melanoma

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00667953
First received: April 24, 2008
Last updated: December 2, 2011
Last verified: December 2011

April 24, 2008
December 2, 2011
January 2003
December 2010   (final data collection date for primary outcome measure)
To determine the safety and efficacy of combination therapy with Gleevec and Temzolomide in patients with advanced melanoma. [ Time Frame: Interim analysis after accrual of 17 patients ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00667953 on ClinicalTrials.gov Archive Site
To evaluate the secondary endpoints of time to disease progression, duration of response, and overall survival of patients receiving Gleevec + Temozolomide [ Time Frame: Interim analysis after accruing 17 patients ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study of Temzolomide and Gleevec in Advanced Melanoma
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Melanoma
  • Advanced Melanoma
Drug: Gleevec + Temozolomide
Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle. Gleevec (600 mg) daily.
Experimental: Arm A:
Intervention: Drug: Gleevec + Temozolomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
March 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00667953
UPCC 02602
No
Lynn Schuchter, M.D., University of Pennsylvania
University of Pennsylvania
Novartis Pharmaceuticals
Not Provided
University of Pennsylvania
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP