Phase II Study of Abraxane Plus Ipilimumab in Patients With Metastatic Melanoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01827111
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • ABI-007 — DRUG
    Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. The cycle length for ABI-007 is 28 days.
  • Ipilimumab — DRUG
    3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses.
  • Phone Call — BEHAVIORAL
    Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes.

Study Details

The goal of this clinical research study is to learn if the combination of ipilimumab and ABI-007 (abraxane) can help to control metastatic melanoma. The safety of this drug combination will also be studied. Ipilimumab is designed to increase the immune system's ability to fight cancer. Abraxane is designed to stop cancer cells from making new DNA (the genetic material of cells). This may stop the cancer cells from dividing into new cells.

Key Dates

Start date
Apr 25, 2013
Status verified
Jan 2022
Primary completion
Sep 21, 2020
Completion
Sep 21, 2020

Study Design

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

Arms

  • Experimental: ABI-007 + Ipilimumab
    Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. Ipilimumab 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses. Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes.

Primary Outcome Measure

Median Overall Survival Response to Abraxane Plus Ipilimumab Therapy [ 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 50 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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