Evaluation of Tumor Response to Ipilimumab in the Treatment of Melanoma With Brain Metastases

Summary

To assess the response of melanoma with brain metastases to ipilimumab treatment while maintaining acceptable tolerability.

Conditions

• Melanoma

Interventions

DRUG

Ipilimumab

10 mg/kg, administered as an intravenous infusion every 3 weeks during induction and every 12 weeks during maintenance

DRUG

Corticosteroid: Betamethasone

Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with betamethasone

DRUG

Corticosteroid: Dexamethasone

Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with dexamethasone

DRUG

Corticosteroid: Fludrocortisone

Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with fludrocortisone

DRUG

Corticosteroid: Hydrocortisone

Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with hydrocortisone

DRUG

Corticosteroid: Meprednisone

Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with meprednisone

DRUG

Corticosteroid: Methylprednisolone

Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with methylprednisolone

DRUG

Corticosteroid: Prednisolone

Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with prednisolone

DRUG

Corticosteroid: Prednisone

Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with prednisone

DRUG

Corticosteroid: Triamcinolone

Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with triamcinolone

Sponsors & Collaborators

• Medarex

  collaborator INDUSTRY

• Bristol-Myers Squibb

  lead INDUSTRY

Principal Investigators

• Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-07-31

Primary Completion

2009-09-30

Completion

2012-10-31

Countries

• United States

Study Locations