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Recurrent Neuroendocrine Carcinoma of the SkinPhase 2NCT00068783

S0331: Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer

A Phase 2 study testing imatinib mesylate and laboratory biomarker analysis in people with Recurrent Neuroendocrine Carcinoma of the Skin and Stage II Neuroendocrine Carcinoma of the Skin, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial is studying how well imatinib mesylate works in treating patients with metastatic or unresectable Merkel cell cancer. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
imatinib mesylate and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
Oct 2003to Jun 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 26Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Southwest Oncology Group

    San Antonio, Texas, 78245

Other trials in United States

About this study

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

This phase II trial is studying how well imatinib mesylate works in treating patients with metastatic or unresectable Merkel cell cancer. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
imatinib mesylate, laboratory biomarker analysis
Medical subject headings
Carcinoma, Merkel Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • imatinib mesylateDrug

    Also called CGP 57148, Gleevec, Glivec

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00068783
Study groupRoleWhat they receive
TreatmentExperimentalPatients 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.
Receives: Drug: imatinib mesylate; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response probability

    Measured: Up to 4 years

Secondary outcomes (4)

  1. Toxicity rates

    Estimated with 95% confidence interval.

    Measured: Up to 4 years

  2. Mutation rate for KIT

    Estimated with 95% confidence interval.

    Measured: Baseline

  3. Mutation rate for PDGFRA

    Estimated with 95% confidence interval.

    Measured: Baseline

  4. Mutation rate for PDGFRB

    Estimated with 95% confidence intervals.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2003 (estimated)
  2. Study startOct 2003
  3. Primary completionJun 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00068783
Sponsor's protocol ID
NCI-2012-03182
Other IDs
S0331, U10CA032102, CDR0000328120
Status last verified
Feb 2013
First submitted
10 Sep 2003
Last updated
28 Feb 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing imatinib mesylate and laboratory biomarker analysis in people with Recurrent Neuroendocrine Carcinoma of the Skin and Stage II Neuroendocrine Carcinoma of the Skin, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response probability (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00068783.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2013.

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