COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00070343
Recruitment Status : Unknown
Verified November 2004 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : October 7, 2003
Last Update Posted : January 6, 2014
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: oblimersen sodium Drug: dacarbazine Not Applicable

Detailed Description:



  • 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.


  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Continuation Protocol For G3139 (Bcl-2 Antisense Oligonucleotide) And Dacarbazine In Patients With Malignant Melanoma Who Responded To This Combination In Protocol GM301
Study Start Date : August 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Dacarbazine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Any age

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • 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


  • 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


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


  • 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


  • 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


Biologic therapy

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


  • 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)


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


  • At least 4 weeks since prior major surgery and recovered


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00070343

Layout table for location information
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-6996
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Layout table for investigator information
Principal Investigator: John A. Glaspy, MD, MPH Jonsson Comprehensive Cancer Center
Layout table for additonal information Identifier: NCT00070343    
Other Study ID Numbers: CDR0000331927
First Posted: October 7, 2003    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: November 2004
Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
stage III melanoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents