Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 03-105 | |||
| CDR0000354418 | |||
| NCI-5907 | |||
| MSKCC-03105 | |||
| N01CM62207 | U.S. NIH Grant/Contract | View source | |
| N01CM62206 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (oblimersen sodium) | Experimental | Patients receive oblimersen IV continuously on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oblimersen sodium | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | Progression-free survival probabilities will be computed using Kaplan-Meier methods. | Interval between the start of treatment and until the criteria for progression are met, assessed up to 3 years |
| Occurrence of adverse events, assessed using revised NCI CTC version 3.0 |
Not provided
Inclusion Criteria:
Histologically or cytologically confirmed Merkel cell carcinoma
Measurable disease
No known brain metastases
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ki Chung | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| pharmacological study | Other | Correlative studies |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| Within 30 days of treatment |
| ID | Term |
|---|---|
| D015266 | Carcinoma, Merkel Cell |
| ID | Term |
|---|---|
| D027601 | Polyomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| C408162 | oblimersen |
Not provided
Not provided
Not provided