Study of Temzolomide and Gleevec in Advanced Melanoma

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00667953
• Other study ID #: UPCC 02602
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: January 2003
• Est. completion date: March 9, 2011

Study information

• Verified date: March 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: March 9, 2011
• Est. primary completion date: March 9, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• 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

Related Conditions & MeSH terms

• Advanced Melanoma
• Melanoma

Intervention

Drug:
• Gleevec
Gleevec (600 mg) daily.
• Temodar
Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle.

Locations

Country	Name	City	State
United States	Abramson Cancer Center at University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bajor DL, Xu X, Torigian DA, Mick R, Garcia LR, Richman LP, Desmarais C, Nathanson KL, Schuchter LM, Kalos M, Vonderheide RH. Immune activation and a 9-year ongoing complete remission following CD40 antibody therapy and metastasectomy in a patient with me — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Grade 3 or 4 Adverse Events	Number of reported grade 3 or 4 adverse events	through study completion, an average of 1 year
Secondary	Response	Response rate by RECIST	through study completion, an average of 1 year
Secondary	To Evaluate the Secondary Endpoints of Time to Disease Progression, Duration of Response, and Overall Survival of Patients Receiving Gleevec + Temozolomide		through study completion