Trial of Ipilimumab After Isolated Limb Perfusion, in Patients With Metastases Melanoma

Conditions

• In-transit Metastases Melanoma Stage IIIB and IIIC

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ipilimumab — DRUG
  Ipilimumab is to be administered as an IV infusion with a 1.2μm in-line filter (see current version of Investigator's Brochure), using a volumetric pump, at the 3 mg/kg dose, at the ratio and rate specified in the pharmacy manual, to complete the infusion in 90 minutes with a 100 cc normal saline flush at the end. The total dose needed should be diluted to a total volume of 250 mL in 0.9% sodium chloride injection, USP or 5% Dextrose Injection, USP.. The total dose must be calculated using the most recent subject weight (obtained on the same day of, and prior to, the infusion). If the patient weighs more than 125,0 kg, the Coordinating Investigator needs to be contacted to discuss the total infusion volume, infusion rate and duration. Ipilimumab 3 mg/kg will be administered as a single dose intravenously over 90 minutes every 3 weeks for 4 cycles (Weeks W1, W4, W7, W10). A time interval of +/- 3 days is allowed for Ipilimumab administration.

Study Details

Isolated limb perfusion (ILP) results in good response rates for locally advanced melanoma (stage IIIB and IIIC, AJCC 2009). Outcome is influenced by stage of disease, reflecting the aggressiveness of the melanoma. Our objective is to demonstrate at least a doubling of the progression free survival for the patients having an adjuvant treatment by Ipilimumab in this patient population with unfavourable characteristics. PFS ranges from 10-12 months. So at least a doubling of this period would be a clinically highly significant result.

Key Dates

Start date

Mar 31, 2014

Status verified

Jun 2016

Primary completion

Feb 29, 2016

Completion

Feb 29, 2016

Study Design

Enrollment

4 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ipilimumab
• No Intervention: No Ipilimumab

Primary Outcome Measure

Time to progression, local progression or distant progression [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 9 months ]