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Treatment of Resistant Metastatic Melanoma Using Decitabine, Temozolomide and Panobinostat

NCT00925132 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2017-07-02

Study results available
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Summary

The purpose of this study is to treat metastatic melanoma with a combination of standard chemotherapy (decitabine and Temozolomide in a dose escalation scheme) with an study drug called panobinostat. This combination is proposed to unlock genes that may contribute to mechanisms that cause tumor growth.

The primary objectives of this study are:

* To evaluate the safety and tolerability of the proposed schedule of decitabine, temozolomide and panobinostat in the treatment of metastatic melanoma.
* To define any Dose Limiting Toxicity (DLT) and maximum tolerated dose (MTD) of the combination of decitabine, temozolomide and panobinostat.

Conditions

Interventions

DRUG

Temozolomide, Decitabine, Panobinostat

Temozolomide - given each cycle. Decitabine - 6 cohorts with dose escalation. Panobinostat - 6 cohorts with dose escalation.

Sponsors & Collaborators

  • Holden Comprehensive Cancer Center

    collaborator OTHER

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • University of Iowa

    lead OTHER

Principal Investigators

  • Mohammed Milhem, MD · University of Iowa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2014-11-30
Completion
2016-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00925132 on ClinicalTrials.gov