Study of Temzolomide and Gleevec in Advanced Melanoma - Full Text View

Sponsor:	University of Pennsylvania
Collaborator:	Novartis
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00667953

Purpose

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	Intervention	Phase
Melanoma Advanced Melanoma	Drug: Gleevec + Temozolomide	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase I/II Study of Temozolomide and Gleevec (Imatinib Mesylate, Formerly Known as STI571) in Advanced Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Melanoma

Drug Information available for: Temozolomide Imatinib Imatinib mesylate

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	56
Study Start Date:	January 2003
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667953

Locations

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

Sponsors and Collaborators

University of Pennsylvania

Novartis

More Information

No publications provided

Responsible Party:	University of Pennsylvania ( Lynn Schuchter, M.D. )
Study ID Numbers:	UPCC 02602
Study First Received:	April 24, 2008
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00667953 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pennsylvania:

Temzolomide
Gleevec
Melanoma
Advanced melanoma
Phase II

Additional relevant MeSH terms:

Nevi and Melanomas
Melanoma
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Protein Kinase Inhibitors
Temozolomide

Pharmacologic Actions
Neuroendocrine Tumors
Imatinib
Neuroectodermal Tumors
Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on November 27, 2009