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

Phase 1/Phase 2
18 Years
Not Enrolling
Melanoma, Advanced Melanoma

Thank you

Trial Information

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

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safety and efficacy of combination therapy with Gleevec and Temzolomide in patients with advanced melanoma.

Outcome Time Frame:

Interim analysis after accrual of 17 patients

Safety Issue:



United States: Institutional Review Board

Study ID:

UPCC 02602



Start Date:

January 2003

Completion Date:

March 2011

Related Keywords:

  • Melanoma
  • Advanced Melanoma
  • Temzolomide
  • Gleevec
  • Melanoma
  • Advanced melanoma
  • Phase II
  • Melanoma



Abramson Cancer Center at University of PennsylvaniaPhiladelphia, Pennsylvania  19104