Study of Temzolomide and Gleevec in Advanced Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00667953
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : August 29, 2018
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Melanoma Advanced Melanoma Drug: Gleevec + Temozolomide Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Temozolomide and Gleevec (Imatinib Mesylate, Formerly Known as STI571) in Advanced Melanoma
Study Start Date : January 2003
Actual Primary Completion Date : March 2011

Arm Intervention/treatment
Experimental: Arm A: Drug: Gleevec + Temozolomide
Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle. Gleevec (600 mg) daily.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00667953

United States, Pennsylvania
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Novartis Pharmaceuticals

Responsible Party: Abramson Cancer Center of the University of Pennsylvania Identifier: NCT00667953     History of Changes
Other Study ID Numbers: UPCC 02602
First Posted: April 28, 2008    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Advanced melanoma
Phase II

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Imatinib Mesylate
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors