IPI-Biotherapy for Patients Previously Treated With Cytotoxic Drugs With Metastatic Melanoma

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01409187
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
    Starting dose 2 mg/kg by vein on day 1 of each of the four 3-week cycles (Phase II is maximum tolerated dose (MTD) from Phase I). During Consolidation and Maintenance phases one dose every 12 weeks.
  • Interferon — DRUG
    5 million U/m2 subcutaneously daily for 5 days starting day 1 of each Induction and Consolidation cycle.
  • Interleukin-2 (Aldesleukin) — DRUG
    9 million IU/m\^2 daily by vein by continuous infusion for 4 days (total of 96 hours, days 2-5) starting day 2 of each Induction and Consolidation cycle.

Study Details

The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of the drug Yervoy (ipilimumab) that can be given with the drugs Intron-A (interferon alfa-2b) and Proleukin (aldesleukin, IL-2) to patients with metastatic melanoma. The safety of this combination will also be studied in Phase I. The goal of Phase II is to learn if this combination can help to control metastatic melanoma. Ipilimumab, interferon alfa-2b, and aldesleukin are designed to block the activity of cells that decrease the immune system's ability to fight cancer.

Key Dates

Start date
Oct 31, 2011
Status verified
Jan 2012
Primary completion
Oct 31, 2016

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab + Interferon + Interleukin-2
    Ipilimumab starting dose 2 mg/kg intravenous (IV) day 1 only; IFN alfa-2b at 5 million U/m2 subcutaneously daily for 5 days starting day 1; IL-2 at 9 million IU/m\^2 daily IV continuous infusion for 4 days on days 2-5.

Primary Outcome Measure

Progression Free survival (PFS) [ Time Frame: Assessed at 6-months then until disease progression or death. ]

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