My Journey

The trial that I’m participating in is now open to additional participants who will be also given steroid treatment

Clinical Trial Registry

Overall Recruitment Status: Recruiting

Condition(s): Melanoma

Intervention(s): Ipilimumab, Steroids

Phase: Phase 2

Study Type: Treatment

Study Design: Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title: A Multi-Center Phase II Study to Evaluate Tumor Response to Ipilimumab (BMS-734016) Monotherapy in Subjects With Melanoma Brain Metastases

Primary Outcome Measures:

Tumor assessment
Time Frame : after 12 weeks of first dose and then every 6 weeks

Secondary Outcome Measures:

Progression free survival – Incidence of MRI defined brain edema
Time Frame : End of Study

Safety and tolerability of treatment
Time Frame : Every study visit

Response of tumor in presence or absence of corticosteroids
Time Frame : Every 12 weeks

Arms	Assigned Interventions
Ipilimumab + Steroids:Experimental	Drug:Ipilimumab IV, 10 mg/kg, every 3 weeks during induction; every 12 weeks during maintenance, 9-12 months depending on response
Ipilimumab + Steroids:Experimental	Drug:Steroids Oral, tablets, 10 mg/kg, every 3 weeks during induction; every 12 weeks during maintenance, 9-12 months depending on response

Estimated Enrollment: 62

Study Start Date: March 2008

Estimated Study Completion Date: December 2009

Estimated Primary Completion Date: December 2009

Download Date: Information obtained from ClinicalTrials.gov on June 12, 2009

Link Text: Link to the current ClinicalTrials.gov record.

URL: http://clinicaltrials.gov/show/NCT00623766

Eligibility

Minimum age: 16 Years

Maximum age: N/A

Gender(s): Both

Criteria :
Inclusion Criteria:

• Malignant melanoma with measurable brain metastases
• At least one measurable index metastatic brain lesion, with its greatest dimension > 0.5 cm and no larger than 3 cm in diameter, that has not been previously irradiated, and/or at least 2 measurable lesions > 0.3 cm that a re visible on contrast-enhanced MRI
• ECOG 0-1
• Stable labs
• Age > /= 16 years
  Exclusion

• Auto immune disease, Hepatitis or HIV, other cancer
• Previous treatment with other CTLA-4 agonists, or concurrent IL-2 therapy
• Major surgery within 28 days
• Prior stereotactic or highly conformal radiotherapy and/or whole brain irradiation within 14 days prior to start of ipilimumab dosing for this study

General Contact Information
For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
First line of email MUST contain NCT#& Site#. Only trial sites that are recruiting have contact information at this time.

check the Bristol-Myers Squibb clinical trials page for more info.

http://www.bms.com/clinical_trials/Pages/clinical_trial_registry.aspx