NCT00079131

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2004

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

3 years

First QC Date

March 8, 2004

Last Update Submit

June 3, 2013

Conditions

Recurrent Neuroendocrine Carcinoma of the SkinStage I Neuroendocrine Carcinoma of the SkinStage II Neuroendocrine Carcinoma of the SkinStage III Neuroendocrine Carcinoma of the SkinStage IV Neuroendocrine Carcinoma of the Skin

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

    Up to 3 years

Secondary Outcomes (2)

  • Time to progression

    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

    Within 30 days of treatment

Study Arms (1)

Treatment (oblimersen sodium)

EXPERIMENTAL

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 sodiumOther: pharmacological studyOther: laboratory biomarker analysis

Interventions

oblimersen sodiumBIOLOGICAL

Given IV

Also known as: augmerosen, G3139, G3139 bcl-2 antisense oligodeoxynucleotide, Genasense
Treatment (oblimersen sodium)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (oblimersen sodium)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (oblimersen sodium)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Carcinoma, Merkel Cell

Interventions

oblimersen

Condition Hierarchy (Ancestors)

Polyomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Ki Chung

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2004

First Posted

March 9, 2004

Study Start

January 1, 2004

Primary Completion

January 1, 2007

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

US(1)