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
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Temozolomide and Gleevec (Imatinib Mesylate, Formerly Known as STI571) in Advanced Melanoma

Resource links provided by NLM:


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
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Pharmaceuticals
  More Information

No publications provided

Responsible Party: Lynn Schuchter, M.D., University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00667953     History of Changes
Other Study ID Numbers: UPCC 02602
Study First Received: April 24, 2008
Last Updated: December 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Temzolomide
Gleevec
Melanoma
Advanced melanoma
Phase II

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

ClinicalTrials.gov processed this record on October 19, 2014