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Oblimersen in Treating Patients With Merkel Cell Carcinoma

Primary Purpose

Recurrent Neuroendocrine Carcinoma of the Skin, Stage I Neuroendocrine Carcinoma of the Skin, Stage II Neuroendocrine Carcinoma of the Skin

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
oblimersen sodium
pharmacological study
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Neuroendocrine Carcinoma of the Skin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (oblimersen sodium)

Arm Description

Patients receive oblimersen IV continuously on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Overall response rate

Secondary Outcome Measures

Time to progression
Progression-free survival probabilities will be computed using Kaplan-Meier methods.
Occurrence of adverse events, assessed using revised NCI CTC version 3.0

Full Information

First Posted
March 8, 2004
Last Updated
June 3, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00079131
Brief Title
Oblimersen in Treating Patients With Merkel Cell Carcinoma
Official Title
A Phase II Study of G3139 (Genasense ™) in Patients With Merkel Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (oblimersen sodium)
Arm Type
Experimental
Arm Description
Patients receive oblimersen IV continuously on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Biological
Intervention Name(s)
oblimersen sodium
Other Intervention Name(s)
augmerosen, G3139, G3139 bcl-2 antisense oligodeoxynucleotide, Genasense
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
pharmacological study
Other Intervention Name(s)
pharmacological studies
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Time to progression
Description
Progression-free survival probabilities will be computed using Kaplan-Meier methods.
Time Frame
Interval between the start of treatment and until the criteria for progression are met, assessed up to 3 years
Title
Occurrence of adverse events, assessed using revised NCI CTC version 3.0
Time Frame
Within 30 days of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki Chung
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

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Oblimersen in Treating Patients With Merkel Cell Carcinoma

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