Oblimersen in Treating Patients With Merkel Cell Carcinoma
Completed · Phase 2
Conditions studied: 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
In brief
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).
Key facts
- Study ID
- NCT00079131
- Run by
- National Cancer Institute (NCI)
- People needed
- 37
- Starts
- 2004-01-01
- Last updated by the study team
- 2013-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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