RATIONALE: Biological therapies, such as oblimersen, may interfere with the growth of tumor cells and slow the growth of Merkel cell carcinoma (skin cancer).

PURPOSE: This phase II trial is studying how well oblimersen works in treating patients with metastatic or recurrent Merkel cell cancer.

Condition	Treatment or Intervention	Phase
recurrent Merkel cell carcinoma stage II Merkel cell carcinoma stage III Merkel cell carcinoma	Drug: oblimersen  Procedure: antisense therapy	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Determine the overall response rate in patients with metastatic or recurrent Merkel cell carcinoma treated with oblimersen.

Secondary

• Determine the time to progression in patients treated with this drug.
• Determine the response duration in patients treated with this drug.
• Determine the safety and tolerability of this drug in these patients.
• 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.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 4-10 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• WBC ≥ 3,000/mm^3

Hepatic

• AST/ALT ≤ 2.5 times upper limit of normal
• Bilirubin normal
• INR ≤ 1.5

Renal

• Creatinine normal OR
• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• No atrial fibrillation unless stable for at least the past 6 months
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other

• 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

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• More than 3 weeks since prior chemotherapy and recovered

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• More than 3 weeks since prior radiotherapy and recovered
• No prior radiotherapy to 25% or more of bone marrow

Surgery

• See Disease Characteristics

Other

• 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

Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States; Recruiting
Florida
      H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa,  Florida,  33612,  United States; Recruiting
Massachusetts
      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States; Recruiting
New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
Ohio
      Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus,  Ohio,  43210-1240,  United States; Recruiting

Study chairs or principal investigators

Jeremy S. Kortmansky, MD,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000354418; MSKCC-03105; NCI-5907; NCT00079131
Record last reviewed:  August 2004
Last Updated:  April 5, 2005
Record first received:  March 8, 2004
ClinicalTrials.gov Identifier:  NCT00079131
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08