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Systemic Therapy With Interferon, Interleukin-2 and BRAF Inhibitor

NCT01603212 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2019-05-21

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 vemurafenib and Aldesleukin (interleukin-2) that can be given in combination with interferon alfa-2b in patients with advanced or metastatic melanoma. The safety of this combination will also be studied.

The goal of Phase II is to learn if this study drug combination can help to control advanced or metastatic melanoma.

Conditions

Interventions

DRUG

Vemurafenib

Phase I Starting dose: 720 mg by mouth twice a day for a 21 day cycle. Phase II Starting dose: Maximum tolerated dose (MTD) from Phase I.

DRUG

IL-2

Phase I Starting Dose: 7 million IU/m2 by vein on Days 2 - 5 of a 21 day cycle. Phase II Starting Dose: Maximum tolerated dose (MTD) from Phase I.

DRUG

Interferon Alpha-2b

5 million U/m2 subcutaneously on Days 1 - 5 of a 21 day cycle.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Rodabe N. Amaria, MD · M.D. 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
2013-07-18
Primary Completion
2017-07-05
Completion
2017-07-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01603212 on ClinicalTrials.gov