Completed

A Phase II Study of G3139 (Genasense ™) in Patients With Merkel Cell Carcinoma

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What is being tested

oblimersen sodium

+ pharmacological study

+ laboratory biomarker analysis

BiologicalOther
Who is being recruted

Adenocarcinoma+16

+ Carcinoma

+ DNA Virus Infections

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2004
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2004

Actual date on which the first participant was enrolled.

PRIMARY OBJECTIVES: I. Determine the overall response rate in patients with Merkel cell carcinoma treated with oblimersen. SECONDARY OBJECTIVES: I. Determine the time to progression in patients treated with this drug. II. Determine the response duration in patients treated with this drug. III. Determine the safety and tolerability of this drug in these patients. IV. Determine the pharmacodynamic effects of this drug on bcl-2 expression and apoptosis in tumor biopsy specimens from these patients. OUTLINE: This is an open-label, multicenter study. Patients receive oblimersen IV continuously on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Official TitleA Phase II Study of G3139 (Genasense ™) in Patients With Merkel Cell Carcinoma 
NCT00079131
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

37 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaCarcinomaDNA Virus InfectionsInfectionsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueSkin DiseasesSkin NeoplasmsTumor Virus InfectionsVirus DiseasesCarcinoma, Merkel CellNeuroectodermal TumorsCarcinoma, NeuroendocrineNeuroendocrine TumorsPolyomavirus Infections

Criteria

Inclusion Criteria: * Histologically or cytologically confirmed Merkel cell carcinoma * Metastatic OR regionally recurrent disease * Localized disease not amenable to curative therapy (surgery or radiotherapy) also allowed * Measurable disease * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * No known brain metastases * Previously resected or irradiated brain metastases allowed if stable for at least the past 3 months and no evidence of neurological compromise exists * Performance status - Karnofsky 60-100% * Absolute neutrophil count \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * WBC \>= 3,000/mm\^3 * AST/ALT =\< 2.5 times upper limit of normal * Bilirubin normal * INR =\< 1.5 * Creatinine normal * Creatinine clearance \>= 60 mL/min * No atrial fibrillation unless stable for at least the past 6 months * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Adequate venous access * No peripheral neuropathy \> grade 1 * No active or ongoing infection * No other concurrent uncontrolled illness * No prior grade 3 or 4 anaphylactic reaction to phosphorothioate oligonucleotide * No psychiatric illness or social situation that would preclude study compliance * More than 3 weeks since prior chemotherapy and recovered * More than 3 weeks since prior radiotherapy and recovered * No prior radiotherapy to 25% or more of bone marrow * More than 3 weeks since prior investigational therapy and recovered * No prior oblimersen * No other concurrent investigational agents * No concurrent anticoagulation except 1 mg of warfarin for mediport patency * No concurrent combination antiretroviral therapy for HIV-positive patients

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive oblimersen IV continuously on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Memorial Sloan-Kettering Cancer Center

New York, United StatesSee the location
CompletedOne Study Center