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Temozolomide and Bevacizumab in Treating Patients With Metastatic Melanoma of the Eye

NCT ID: NCT01217398

Last Updated: 2013-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Brief Summary

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RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving temozolomide together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying giving temozolomide together with bevacizumab to see how well they work in treating patients with metastatic melanoma of the eye.

Detailed Description

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OBJECTIVES:

Primary

* To evaluate the efficacy of temozolomide in combination with bevacizumab in treating patients with metastatic uveal melanoma not amenable to curative surgery.

Secondary

* To determine response rate in these patients.
* To determine duration of response in these patients.
* To determine progression-free survival of these patients.
* To determine overall survival of these patients.
* To determine the safety of treatment with this regimen in these patients.
* To study the CT perfusion imaging for functional imaging of response in these patients.
* To determine the pharmacogenetic influence of constitutional VEGF-A polymorphism on the efficacy and toxicity of bevacizumab. (ancillary)

OUTLINE: Patients receive oral temozolomide once daily on days 1-7 and 15-21 and bevacizumab IV over 30-90 minutes on days 8 and 22. Treatment repeats every 28 days for up to 6 courses. Patients achieving at least stable disease then receive bevacizumab monotherapy IV every 2 weeks as maintenance therapy in the absence of unacceptable toxicity and disease progression. Patients undergo CT perfusion imaging at baseline, day 28, and at 3 and 6 months.

Blood samples are collected at baseline and then periodically for VEGF-A genetic polymorphism analysis.

After completion of study treatment, patients are followed up at 1 month.

Conditions

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Intraocular Melanoma

Keywords

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ciliary body and choroid melanoma, medium/large size ciliary body and choroid melanoma, small size iris melanoma metastatic intraocular melanoma stage IV intraocular melanoma

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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bevacizumab

Intervention Type BIOLOGICAL

temozolomide

Intervention Type DRUG

polymorphism analysis

Intervention Type GENETIC

pharmacogenomic studies

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* More than 14 days since prior laparoscopic liver biopsy
* More than 28 days since prior major surgery
* More than 28 days since prior participation in another study with experimental treatment
* No other concurrent anticancer treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Curie

OTHER

Sponsor Role lead

Principal Investigators

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Sophie Piperno-Neumann, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Curie

Locations

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Institut Curie Hopital

Paris, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Contact Person

Role: primary

Other Identifiers

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CLCC-IC-2009-01

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2009-011751-46

Identifier Type: -

Identifier Source: secondary_id

EU-21063

Identifier Type: -

Identifier Source: secondary_id

CDR0000683852

Identifier Type: -

Identifier Source: org_study_id