IPI Biochemotherapy for Chemonaive Patients With Metastatic Melanoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01409174
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Ipilimumab — DRUG
    Phase I Starting dose: 1 mg/kg by vein over 90 minutes on Day 1 of each 3 week cycle for Induction 12 weeks, then Day 1 of Cycle 1 for Consolidation 12 weeks and Day 1 of each 12 week cycle in Maintenance. Phase II dose: Maximum tolerated dose (MTD) from Phase I.
  • Temozolomide — DRUG
    200 mg/m\^2 by mouth 1 time a day on Days 2-5 of each Induction cycle (four 3 week cycles).
  • Cisplatin — DRUG
    25 mg/m\^2 by vein over 1 hour on Days 2-4 of each Induction cycle (four 3 week cycles).
  • Interferon Alfa-2b — DRUG
    5 million U/m2 subcutaneously on Days 2-6 of each 3 week Induction cycle (four 3 week cycles) and each 4 week Consolidation cycle (three 4 week cycles).
  • Interleukin-2 — DRUG
    9 million IU/m\^2 by vein as a continuous infusion on Days 2-5 of each 3 week Induction cycle (four 3 week cycles) and each 4 week Consolidation cycle (three 4 week cycles).

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 Temodar (temozolomide), Intron-A (interferon alfa-2b), Proleukin (aldesleukin, IL-2), and Platinol (cisplatin) 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. Note: The study was closed following Phase I enrollment. Ipilimumab, interferon alfa-2b, and aldesleukin are designed to block the activity of cells that decrease the immune system's ability to fight cancer. Temozolomide 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. Cisplatin is designed to poison the cancer cells, which may cause them to die.

Key Dates

Start date
Feb 28, 2013
Status verified
May 2017
Primary completion
May 31, 2016
Completion
May 31, 2016

Study Design

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

Arms

  • Experimental: Ipilimumab + Chemotherapy
    Ipilimumab starting 1 mg/kg by vein (IV) Day 1 each cycle; Temozolomide 200 mg/m\^2 orally Days 2-5 of Induction; Cisplatin 25 mg/m\^2 IV for Days 2-4 of Induction; Interferon alfa-2b 5 million U/m2 subcutaneously on Days 1-5 of each cycle Induction + Consolidation; and Interleukin-2 9 million IU/m\^2 IV as a continuous infusion on Days 2-5 of Induction + Consolidation.

Primary Outcome Measure

Tumor Response by Participant using immune-related response criteria (irRC) [ Time Frame: End of 2 cycles, 24 weeks ]

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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