Skip to content

Oblimersen in Treating Patients With Merkel Cell Carcinoma

A Phase II Study of G3139 (Genasense ™) in Patients With Merkel Cell Carcinoma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00079131
Enrollment
37
Registered
2004-03-09
Start date
2004-01-31
Completion date
Unknown
Last updated
2013-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BIOLOGICALoblimersen sodium

Given IV

OTHERpharmacological study

Correlative studies

OTHERlaboratory biomarker analysis

Correlative studies

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Overall response rateUp to 3 years

Secondary

MeasureTime frameDescription
Time to progressionInterval between the start of treatment and until the criteria for progression are met, assessed up to 3 yearsProgression-free survival probabilities will be computed using Kaplan-Meier methods.
Occurrence of adverse events, assessed using revised NCI CTC version 3.0Within 30 days of treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026