NCT00667953

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2011

Completed
12.1 years until next milestone

Results Posted

Study results publicly available

March 30, 2023

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

8.2 years

First QC Date

April 24, 2008

Results QC Date

August 25, 2021

Last Update Submit

March 7, 2023

Conditions

MelanomaAdvanced Melanoma

Keywords

TemzolomideGleevecMelanomaAdvanced melanomaPhase II

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Response

    through study completion, an average of 1 year

  • To Evaluate the Secondary Endpoints of Time to Disease Progression, Duration of Response, and Overall Survival of Patients Receiving Gleevec + Temozolomide

    through study completion

Study Arms (1)

Arm A:

EXPERIMENTAL

Temozolomide plus imatinib

Drug: GleevecDrug: Temodar

Interventions

GleevecDRUG

Gleevec (600 mg) daily.

Also known as: Imatinib mesylate
Arm A:
TemodarDRUG

Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle.

Also known as: temozolomide
Arm A:

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related 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 metastatic melanoma. Cancer Immunol Res. 2014 Nov;2(11):1051-8. doi: 10.1158/2326-6066.CIR-14-0154. Epub 2014 Sep 24.

    PMID: 25252722RESULT

MeSH Terms

Conditions

Melanoma

Interventions

Imatinib MesylateTemozolomide

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesDacarbazineTriazenesImidazolesAzoles

Results Point of Contact

Title
Tara C Mitchell
Organization
Penn
Tara.Mitchell@pennmedicine.upenn.edu
215-662-4000

Study Officials

  • Leslie Fecher, MD

    Rogel Cancer Center

    PRINCIPAL INVESTIGATOR

  • tara mitchell, MD

    Abramson CC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2008

First Posted

April 28, 2008

Study Start

January 1, 2003

Primary Completion

March 9, 2011

Study Completion

March 9, 2011

Last Updated

March 30, 2023

Results First Posted

March 30, 2023

Record last verified: 2023-03

Locations

US(1)