Oblimersen in Treating Patients With Merkel Cell Carcinoma

June 3, 2013 updated by: National Cancer Institute (NCI)

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

This phase II trial is studying how well oblimersen works in treating patients with Merkel cell cancer. Biological therapies, such as oblimersen, may interfere with the growth of tumor cells and slow the growth of Merkel cell carcinoma (skin cancer).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2

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
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (oblimersen sodium)
Patients receive oblimersen IV continuously on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
Correlative studies
Biological: oblimersen sodium
Given IV
Other Names:
  • augmerosen
  • G3139
  • G3139 bcl-2 antisense oligodeoxynucleotide
  • Genasense
Other: pharmacological study
Correlative studies
Other Names:
  • pharmacological studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate
Time Frame: Up to 3 years
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to progression
Time Frame: Interval between the start of treatment and until the criteria for progression are met, assessed up to 3 years
Progression-free survival probabilities will be computed using Kaplan-Meier methods.
Interval between the start of treatment and until the criteria for progression are met, assessed up to 3 years
Occurrence of adverse events, assessed using revised NCI CTC version 3.0
Time Frame: Within 30 days of treatment
Within 30 days of treatment

Collaborators and Investigators

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

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Ki Chung, Memorial Sloan Kettering 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

January 1, 2004

Primary Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

March 8, 2004

First Submitted That Met QC Criteria

March 8, 2004

First Posted (Estimate)

March 9, 2004

Study Record Updates

Last Update Posted (Estimate)

June 4, 2013

Last Update Submitted That Met QC Criteria

June 3, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-01446
  • N01CM62207 (U.S. NIH Grant/Contract)
  • N01CM62206 (U.S. NIH Grant/Contract)
  • 03-105
  • CDR0000354418
  • NCI-5907
  • MSKCC-03105

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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