Everolimus in Treating Patients With Stage IV Melanoma

Phase 2

Completed

• Conditions: Melanoma (Skin)
• Interventions: Drug: everolimus

• Registration Number: NCT00098553
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as everolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may also stop the growth of melanoma by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well everolimus works in treating patients with stage IV melanoma.

Detailed Description

OBJECTIVES:

Primary

* Determine the median time to disease progression in patients with stage IV malignant melanoma treated with everolimus.

Secondary

* Determine the median overall survival of patients treated with this drug.

* Determine the clinical benefit rates (i.e., stable disease, partial remission, and complete response rates) in patients treated with this drug.

* Determine the toxicity profile of this drug in these patients.

* Determine changes in serum vascular endothelial growth factor levels in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral everolimus once daily for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months until disease progression and then every 4 months for up to 5 years after registration.

Study Timeline

• Study First Submitted: 2004-12-07
• Study First Submitted QC: 2004-12-07
• Study First Posted: 2004-12-08
• Study Start: 2005-04
• Primary Completion: 2007-07
• Study Completion: 2010-02
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-01
• Last Update Posted: 2016-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
everolimus	everolimus	Patients receive oral everolimus once daily for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months until disease progression and then every 4 months for up to 5 years after registration.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with progression-free disease at 16 weeks	at 16 weeks

Secondary Outcome Measures

Name	Time	Method
disease progression	at 16 weeks
Median overall survival	Up to 5 years
Toxicity as measured by CTCAE v. 3.0	Up to 5 years
Tumor response rate for 2 consecutive evaluations at least 8 weeks apart	Up to 5 years

Trial Locations

Locations (90)

Mayo Clinic Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Rush-Copley Cancer Care Center; 🇺🇸 Aurora, Illinois, United States

Joliet Oncology-Hematology Associates, Limited - West; 🇺🇸 Joliet, Illinois, United States

Trinity Medical Center - East; 🇺🇸 Moline, Illinois, United States

Carle Cancer Center at Carle Foundation Hospital; 🇺🇸 Urbana, Illinois, United States

CCOP - Carle Cancer Center; 🇺🇸 Urbana, Illinois, United States

Saint Anthony Memorial Health Centers; 🇺🇸 Michigan City, Indiana, United States

McFarland Clinic, PC; 🇺🇸 Ames, Iowa, United States

Mercy Capitol Hospital; 🇺🇸 Des Moines, Iowa, United States

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