Oblimersen in Treating Patients With Merkel Cell Carcinoma

NCT ID: NCT00079131

Last Updated: 2013-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

oblimersen sodium

Intervention Type: BIOLOGICAL

Given IV

pharmacological study

Intervention Type: OTHER

Correlative studies

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

oblimersen sodium

Given IV

Intervention Type: BIOLOGICAL

pharmacological study

Correlative studies

Intervention Type: OTHER

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

augmerosen; G3139; G3139 bcl-2 antisense oligodeoxynucleotide; Genasense; pharmacological studies

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ki Chung

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

03-105

Identifier Type: -

Identifier Source: secondary_id

CDR0000354418

Identifier Type: -

Identifier Source: secondary_id

NCI-5907

Identifier Type: -

Identifier Source: secondary_id

MSKCC-03105

Identifier Type: -

Identifier Source: secondary_id

N01CM62207

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01CM62206

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-01446

Identifier Type: -

Identifier Source: org_study_id