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A Phase II Trial of STI-571/Imatinib (GleevecĀ®) (NSC-716051) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)


Phase 2
18 Years
N/A
Not Enrolling
Both
Recurrent Neuroendocrine Carcinoma of the Skin, Stage II Neuroendocrine Carcinoma of the Skin, Stage III Neuroendocrine Carcinoma of the Skin

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Trial Information

A Phase II Trial of STI-571/Imatinib (GleevecĀ®) (NSC-716051) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)


PRIMARY OBJECTIVES:

I. To assess the feasibility of a Southwest Oncology Group Phase II trial or oral
STI-571/imatinib (Gleevec) administered to patients with metastatic or unresectable Merkel
cell carcinoma.

II. To evaluate the objective response probability (confirmed and unconfirmed complete and
partial responses) of oral STI-571/imatinib (Gleevec) administered to patients with
metastatic or unresectable Merkel cell carcinoma.

III. To assess qualitative and quantitative toxicities of oral STI-581/imatinib (Gleevec)
administered to patients with metastatic or unresectable Merkel cell carcinoma.

IV. To analyze tumor samples for activating mutations of STI-571/imatinib-sensitive kinases
(KIT, PDGFRA, PDGFRB) by denaturing HPLC and direct DNA sequencing.

OUTLINE: This is a multicenter study.

Patients receive oral imatinib mesylate once daily on days 1-28. Courses repeat every 28
days in the absence of disease progression, unacceptable toxicity, or symptomatic
deterioration.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter.


Inclusion Criteria:



- Patients must have a biopsy-proven diagnosis of Merkel Cell Carcinoma (Cutaneous
Neuroendocrine Carcinoma) that is distantly metastatic or unresectable

- Tumors must beet BOTH of the following criteria:

- The primary must be of skin origin; (patients with unknown primary are not
eligible)

- All patients must have immunohistochemical staining with c-kit (CD117)
expression by tumor documented by DAKO, Benchmark, or similar staining kit

- The institution must plan to submit materials for pathology review

- NOTE: Submission of additional specimens is strongly encouraged

- Patients must have measurable disease; all measurable lesions must be assessed (by
physical examination, CT or MRI scan or plain X-ray) within 28 days prior to
registration; tests to assess non-measurable disease must be performed within 42 days
prior to registration

- Patients with symptomatic, unstable or untreated brain metastases are not eligible;
previous treatment must have been completed at least 28 days prior to registration

- Patients must have a Zubrod performance status of 0-2

- Patients must not have received radiotherapy, chemotherapy, biologic therapy or any
other investigational drug for any reason within 28 days prior to registration; all
toxicities from prior treatment must have been resolved (in the opinion of the
treating investigator); patients whose only disease is within a previous radiation
therapy port must demonstrate clearly progressive disease prior to registration;
patients must have resolution of all toxicities from any prior therapy to =< grade 1
(CTCAE version 3.0); patients must not have had a major surgery (e.g., large chest
and abdominal incisions, major soft tissue resections) within 14 days prior to
registration

- Serum bilirubin =< 3 x the institutional upper limit of normal (including those with
hepatic metastases)

- SGOT or SGPT =< 2.5 x the institutional upper limit of normal (or =< 5 x the
institutional upper limit of normal if hepatic metastases is present)

- Serum creatinine =< 1.5 x the institutional upper limit of normal

- ANC >= 1,000/ul

- Platelet count >= 100,000/ul

- Hemoglobin >= 9 gm/dl (this may be achieved by transfusion if needed)

- Patient must not have class 3/4 cardiac problems as defined by the New York Heart
Association criteria (e.g., congestive heart failure, myocardial infarction within 2
months of study)

- Patient must not have a sever and/or uncontrolled concurrent medical disease (e.g.,
uncontrolled diabetes, uncontrolled chronic renal or liver disease, or active
uncontrolled infection, e.g., HIV)

- Patients must not be pregnant or nursing; for women of reproductive potential, a
negative serum pregnancy test must be done within 7 days prior to registration;
post-menopausal women who have not had their ovaries removed must be amenorrheic for
at least 12 months to be considered of non-childbearing potential; patients of
reproductive potential must agree to employ an effective barrier method of birth
control throughout the study and for up to 3 months following discontinuation of
study drug

- NOTE: oral contraceptives may interact with the study drug and should be used
with caution

- Patients must not be taking therapeutic doses of Coumadin (warfarin) as
anticoagulation at the time of registration; patients requiring therapeutic
anticoagulation may use low molecular weight heparin (e.g., Lovenox) or other agents,
and mini-dose Coumadin (1 mg po QD) as prophylaxis is allowed

- If day 7, 14, or 42 falls on a weekend or holiday, the limit may be extended to the
next working day

- In calculating days of tests and measurements, the day a test or measurement is
dose is considered day 0; therefore, if a test is done on a Monday, the Monday
two weeks later would be considered day 14; this allows for efficient patient
scheduling without exceeding the guidelines

- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
stage I or II cancer from which the patient is currently in complete remission, or
any other cancer from which the patient has been disease-free for 5 years

- All patients must be informed of the investigational nature of this study and must
sign and give written informed consent in accordance with institutional and federal
guidelines

- At the time of patient registration, the treating institution's name and ID number
must be provided to the Data Operations Center in Seattle in order to ensure that the
current (within 365 days) date of institutional review board approval for this study
has been entered into the data base

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response probability

Outcome Time Frame:

Up to 4 years

Safety Issue:

No

Principal Investigator

Wolfram Samlowski

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-03182

NCT ID:

NCT00068783

Start Date:

October 2003

Completion Date:

Related Keywords:

  • Recurrent Neuroendocrine Carcinoma of the Skin
  • Stage II Neuroendocrine Carcinoma of the Skin
  • Stage III Neuroendocrine Carcinoma of the Skin
  • Carcinoma
  • Carcinoma, Merkel Cell
  • Carcinoma, Neuroendocrine
  • Skin Neoplasms
  • Carcinoma, Basal Cell
  • Carcinoma, Basosquamous
  • Carcinoma, Squamous Cell

Name

Location

Southwest Oncology GroupSan Antonio, Texas  78245