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
Biological
Other
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, 2004Actual 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Adenocarcinoma
Carcinoma
DNA Virus Infections
Infections
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Skin Diseases
Skin Neoplasms
Tumor Virus Infections
Virus Diseases
Carcinoma, Merkel Cell
Neuroectodermal Tumors
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Polyomavirus 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.

Given IV

Correlative studies

Correlative studies
Study Objectives
Primary Objectives

Secondary Objectives

Progression-free survival probabilities will be computed using Kaplan-Meier methods.


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 CenterNew York, United StatesSee the location

CompletedOne Study Center
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