Decitabine in Treating Patients With Melanoma or Other Advanced Cancer

February 13, 2013 updated by: California Cancer Consortium

A Phase I Study of the Biologic and Clinical Effects of 5-AZA-2'Deoxycytidine (DAC) in Patients With Advanced Malignancies

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of decitabine in treating patients with stage III or stage IV melanoma or other advanced cancer that has not responded to previous therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Identify dosage level(s) of decitabine (DAC) that show biologic activity and acceptable side effects. II. Describe the side effects and toxicity of DAC at the doses studied. III. Determine the steady state DAC serum levels at the doses studied. IV. Document any clinical responses to DAC.

OUTLINE: A dose escalation schedule for the administration of decitabine (DAC) is being used to determine the MTD and biologically active dose. Patients are given two 12 hour continuous infusions per day, for 3 days at each dose level. A minimum of 3 patients are enrolled at each dose level until dose limiting toxicity (DLT) or biologic activity is observed. If DLT or biologic activity is observed at a particular dose level, an additional 3 patients are enrolled, for a total of 6. If 2 or more patients experience DLT, dose escalation is ceased.

PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Beckman Research Institute, City of Hope
      • Los Angeles, California, United States, 90033-0800
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90033
        • Los Angeles County-University of Southern California Medical Center
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Stage III (nonresectable) and IV melanoma, or any other advanced metastatic malignancy for which all standard therapy has failed Must have at least two cutaneous, mucosal or lymph nodal lesions that can be biopsied or one lesion large enough to be biopsied twice

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Hemoglobin at least 9.0 g/dL Platelet count at least 100,000/mm3 WBC at least 3500/mm3 Absolute granulocyte count at least 1500/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT less than 2.5 times normal Renal: Creatinine no greater than 1.8 mg/dL Other: Not pregnant Not HIV or hepatitis BsAg positive No major systemic infections No coagulation disorders No major illness of cardiovascular or respiratory systems No symptomatic CNS disease or evidence of cerebral edema

PRIOR CONCURRENT THERAPY: No therapy for cancer within the past month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Cancer Consortium

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Jeffrey S. Weber, MD, PhD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1997

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

September 2, 2004

First Posted (Estimate)

September 3, 2004

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 13, 2013

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065502
  • LAC-USC-0C963
  • NCI-T95-0070

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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