Oblimersen in Treating Patients With Merkel Cell Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00079131
First received: March 8, 2004
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Recurrent Neuroendocrine Carcinoma of the Skin
Stage I Neuroendocrine Carcinoma of the Skin
Stage II Neuroendocrine Carcinoma of the Skin
Stage III Neuroendocrine Carcinoma of the Skin
Stage IV Neuroendocrine Carcinoma of the Skin
Biological: oblimersen sodium
Other: pharmacological study
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of G3139 (Genasense ™) in Patients With Merkel Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall response rate [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: Interval between the start of treatment and until the criteria for progression are met, assessed up to 3 years ] [ Designated as safety issue: No ]
    Progression-free survival probabilities will be computed using Kaplan-Meier methods.

  • Occurrence of adverse events, assessed using revised NCI CTC version 3.0 [ Time Frame: Within 30 days of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 37
Study Start Date: January 2004
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079131

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Investigators
Principal Investigator: Ki Chung Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00079131     History of Changes
Other Study ID Numbers: NCI-2012-01446, 03-105, CDR0000354418, NCI-5907, MSKCC-03105, N01CM62207, N01CM62206
Study First Received: March 8, 2004
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Merkel Cell
Carcinoma, Neuroendocrine
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Polyomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014