NCT00070343

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2003

Completed
Last Updated

January 6, 2014

Status Verified

November 1, 2004

First QC Date

October 3, 2003

Last Update Submit

January 3, 2014

Conditions

Melanoma (Skin)

Keywords

stage IV melanomastage III melanoma

Interventions

oblimersen sodiumBIOLOGICAL
dacarbazineDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-6996, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

oblimersenDacarbazine

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • John A. Glaspy, MD, MPH

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2003

First Posted

October 7, 2003

Study Start

August 1, 2003

Last Updated

January 6, 2014

Record last verified: 2004-11

Locations

US(1)