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Oblimersen in Treating Patients With Merkel Cell Carcinoma

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00079131
Collaborator
(none)
37
Enrollment
1
Location
1
Arm

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Biological: oblimersen sodium
  • Other: pharmacological study
  • Other: laboratory biomarker analysis
 Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. Determine the overall response rate in patients with Merkel cell carcinoma treated with oblimersen.
SECONDARY OBJECTIVES:
  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of G3139 (Genasense ™) in Patients With Merkel Cell Carcinoma
Study Start Date :
Jan 1, 2004
Actual Primary Completion Date :
Jan 1, 2007

Arms and Interventions

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.

Biological: oblimersen sodium
Given IV
Other Names:
  • augmerosen
  • G3139
  • G3139 bcl-2 antisense oligodeoxynucleotide
  • Genasense

    • Other: pharmacological study
    Correlative studies
    Other Names:
  • pharmacological studies

    • Other: laboratory biomarker analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. Overall response rate [Up to 3 years]

    Secondary Outcome Measures

    1. Time to progression [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.

    2. Occurrence of adverse events, assessed using revised NCI CTC version 3.0 [Within 30 days of treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memorial Sloan-Kettering Cancer Center New York New York United States 10065

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Ki Chung, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00079131
    Other Study ID Numbers:
    • NCI-2012-01446
    • 03-105
    • CDR0000354418
    • NCI-5907
    • MSKCC-03105
    • N01CM62207
    • N01CM62206
    First Posted:
    Mar 9, 2004
    Last Update Posted:
    Jun 4, 2013
    Last Verified:
    Jun 1, 2013
    Additional relevant MeSH terms:
    Carcinoma, Merkel Cell
    Carcinoma
    Carcinoma, Neuroendocrine
    Skin Neoplasms
    Oblimersen

    Study Results

    No Results Posted as of Jun 4, 2013