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


Phase 2
18 Years
N/A
Not Enrolling
Both
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

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Time Frame:

Up to 3 years

Safety Issue:

No

Principal Investigator

Ki Chung

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01446

NCT ID:

NCT00079131

Start Date:

January 2004

Completion Date:

Related Keywords:

  • 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
  • Carcinoma
  • Carcinoma, Merkel Cell
  • Carcinoma, Neuroendocrine
  • Skin Neoplasms
  • Carcinoma, Basal Cell
  • Carcinoma, Basosquamous
  • Carcinoma, Squamous Cell

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021