NCT00068783

Brief 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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2003

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2003

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Last Updated

February 28, 2013

Status Verified

February 1, 2013

Enrollment Period

3.7 years

First QC Date

September 10, 2003

Last Update Submit

February 27, 2013

Conditions

Recurrent Neuroendocrine Carcinoma of the SkinStage II Neuroendocrine Carcinoma of the SkinStage III Neuroendocrine Carcinoma of the Skin

Outcome Measures

Primary Outcomes (1)

  • Response probability

    Up to 4 years

Secondary Outcomes (4)

  • Toxicity rates

    Up to 4 years

  • Mutation rate for KIT

    Baseline

  • Mutation rate for PDGFRA

    Baseline

  • Mutation rate for PDGFRB

    Baseline

Study Arms (1)

Treatment

EXPERIMENTAL

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.

Drug: imatinib mesylateOther: laboratory biomarker analysis

Interventions

imatinib mesylateDRUG

Given orally

Also known as: CGP 57148, Gleevec, Glivec
Treatment
laboratory biomarker analysisOTHER

Correlative studies

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Oncology Group

San Antonio, Texas, 78245, United States

Location

MeSH Terms

Conditions

Carcinoma, Merkel Cell

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Polyomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Wolfram Samlowski

    SWOG Cancer Research Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2003

First Posted

September 11, 2003

Study Start

October 1, 2003

Primary Completion

June 1, 2007

Last Updated

February 28, 2013

Record last verified: 2013-02

Locations

US(1)