Oblimersen and Dacarbazine in Treating Patients With Advanced Malignant Melanoma That Has Responded to Treatment on Clinical Trial GENTA-GM301

January 3, 2014 updated by: Jonsson Comprehensive Cancer Center

Continuation Protocol For G3139 (Bcl-2 Antisense Oligonucleotide) And Dacarbazine In Patients With Malignant Melanoma Who Responded To This Combination In Protocol GM301

RATIONALE: Drugs used in chemotherapy, such as dacarbazine, use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may help dacarbazine kill more tumor cells by making them more sensitive to the drug.

PURPOSE: This clinical trial is studying how well giving oblimersen together with dacarbazine works in treating patients with advanced malignant melanoma that previously responded to treatment with oblimersen and dacarbazine on clinical trial GENTA-GM301.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Provide continuation therapy with oblimersen (G3139) and dacarbazine to patients with advanced malignant melanoma who obtained response or stabilization of disease after prior treatment with this therapy on GENTA-GM301.

Secondary

  • Determine serious adverse events in patients treated with this regimen.

OUTLINE: This is a nonrandomized, open-label, multicenter, continuation study.

Patients receive oblimersen (G3139) IV continuously on days 1-5 and dacarbazine IV over 1 hour on day 5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients who complete 8 courses of treatment may receive additional courses at the discretion of the physician.

Patients are followed every 2 months for up to 2 years after initiation of GENTA-GM301 protocol.

PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Not Applicable

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
      • Los Angeles, California, United States, 90095-6996
        • Jonsson Comprehensive Cancer Center, UCLA

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed advanced malignant melanoma

    • Unresectable or metastatic disease

  • Previously enrolled on GENTA-GM301 protocol

    • Complete or partial objective response or stable disease after completion of 8 courses of oblimersen (G3139) and dacarbazine on arm II of GENTA-GM301
  • Measurable or evaluable disease
  • No uncontrolled brain metastases or leptomeningeal disease

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3*
  • Platelet count at least 100,000/mm^3*
  • Hemoglobin at least 8 g/dL* NOTE: *Hematopoietic growth factor or transfusion independent

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN
  • Albumin at least 2.5 g/dL
  • PTT no greater than 1.5 times ULN
  • PT no greater than 1.5 times ULN OR
  • INR no greater than 1.3
  • No history of chronic hepatitis or cirrhosis

Renal

  • Creatinine no greater than 1.5 times ULN OR
  • Creatinine clearance at least 50 mL/min

Cardiovascular

  • No uncontrolled congestive heart failure
  • No active symptoms of coronary artery disease, defined as uncontrolled arrhythmias or recurrent chest pain despite prophylactic medication
  • No New York Heart Association class III or IV heart disease
  • No cardiovascular signs and symptoms grade 2 or greater within the past 4 weeks

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other significant medical disease
  • No uncontrolled seizure disorder
  • No active infection
  • No uncontrolled diabetes mellitus
  • No active autoimmune disease
  • No known hypersensitivity to phosphorothioate-containing oligonucleotides or dacarbazine
  • No intolerance to prior oblimersen and dacarbazine, including discontinuation of protocol therapy due to 1 or more adverse events
  • HIV negative
  • Satisfactory venous access for a 5-day continuous infusion
  • Intellectually, emotionally, and physically able to maintain an ambulatory infusion pump

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 4 weeks since prior biologic therapy, immunotherapy, cytokine therapy, or vaccine therapy and recovered
  • No concurrent anticancer biologic therapy

Chemotherapy

  • See Disease Characteristics
  • No other concurrent anticancer chemotherapy

Endocrine therapy

  • No concurrent chronic corticosteroids (average dose of at least 20 mg/day of prednisone or equivalent)

Radiotherapy

  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent anticancer radiotherapy

Surgery

  • At least 4 weeks since prior major surgery and recovered

Other

  • At least 4 weeks since other prior therapy and recovered
  • More than 3 weeks since prior experimental therapy (except for GENTA-GM301 protocol)
  • No intervening systemic therapy for melanoma since completion of GENTA-GM301 protocol therapy
  • No other concurrent anticancer therapy, including investigational therapy
  • No concurrent immunosuppressive drugs

  • No concurrent anticoagulation therapy

    • Concurrent warfarin (1 mg/day) for central line prophylaxis is allowed

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
  • Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: John A. Glaspy, MD, MPH, Jonsson Comprehensive Cancer Center

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

August 1, 2003

Study Registration Dates

First Submitted

October 3, 2003

First Submitted That Met QC Criteria

October 6, 2003

First Posted (Estimate)

October 7, 2003

Study Record Updates

Last Update Posted (Estimate)

January 6, 2014

Last Update Submitted That Met QC Criteria

January 3, 2014

Last Verified

November 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000331927
  • UCLA-0307016
  • GENTA-GM214

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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