Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Oblimersen in Treating Patients With Merkel Cell Carcinoma

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Recurrent Neuroendocrine Carcinoma of the Skin

Stage I Neuroendocrine Carcinoma of the Skin

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 ...

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 tre...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    37 Patients enrolled

    Trial Details

    Trial ID

    NCT00079131

    Start Date

    January 1 2004

    Last Update

    June 4 2013

    Active Locations (1)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (1 locations)

    1

    Memorial Sloan-Kettering Cancer Center

    New York, New York, United States, 10065