Study of Temzolomide and Gleevec in Advanced Melanoma

NCT ID: NCT00667953

Last Updated: 2023-03-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2011-03-09

Brief Summary

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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.

Detailed Description

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Conditions

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Melanoma Advanced Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A:

Temozolomide plus imatinib

Group Type EXPERIMENTAL

Gleevec

Intervention Type DRUG

Gleevec (600 mg) daily.

Temodar

Intervention Type DRUG

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

Interventions

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Gleevec

Gleevec (600 mg) daily.

Intervention Type DRUG

Temodar

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

Intervention Type DRUG

Other Intervention Names

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Imatinib mesylate temozolomide

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leslie Fecher, MD

Role: PRINCIPAL_INVESTIGATOR

Rogel Cancer Center

tara mitchell, MD

Role: STUDY_DIRECTOR

Abramson CC

Locations

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Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 25252722 (View on PubMed)

Other Identifiers

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UPCC 02602

Identifier Type: -

Identifier Source: org_study_id

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