Clinical trial · Interventional
Oblimersen in Treating Patients With Merkel Cell Carcinoma
A Phase II Study of G3139 (Genasense ™) in Patients With Merkel Cell Carcinoma
NCT00079131CI-TRIAL-00010551completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Neuroendocrine Carcinoma of the Skin | Cutaneous Merkel Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage III Neuroendocrine Carcinoma of the Skin | Cutaneous Merkel Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage II Neuroendocrine Carcinoma of the Skin | Cutaneous Merkel Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage I Neuroendocrine Carcinoma of the Skin | Cutaneous Merkel Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Neuroendocrine Carcinoma of the Skin | Cutaneous Merkel Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| oblimersen sodium | Biological | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (oblimersen sodium)
- description
- Patients receive oblimersen IV continuously on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: oblimersen sodium
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- Up to 3 years
Secondary outcomes (2)
- measure
- Time to progression
- timeFrame
- Interval between the start of treatment and until the criteria for progression are met, assessed up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.