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

NCT01409187 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2012-01-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Ipilimumab

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.

DRUG

Interferon

5 million U/m2 subcutaneously daily for 5 days starting day 1 of each Induction and Consolidation cycle.

DRUG

Interleukin-2 (Aldesleukin)

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.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Agop Y. Bedikian, MD,BS · UT MD Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2016-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01409187 on ClinicalTrials.gov