Imatinib Mesylate in Treating Patients With Recurrent Ewing's Family of Tumors or Desmoplastic Small Round-Cell Tumor

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00062205

First Posted: June 6, 2003

Last Update Posted: February 9, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

National Cancer Institute (NCI)

Information provided by:

City of Hope Medical Center

Tracking Information

First Submitted Date ^ICMJE

June 5, 2003

First Posted Date ^ICMJE

June 6, 2003

Last Update Posted Date

February 9, 2010

Start Date ^ICMJE

June 2002

Primary Completion Date

June 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Response rate as measured by RECIST criteria

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00062205 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Progression-free survival at 6 months

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Imatinib Mesylate in Treating Patients With Recurrent Ewing's Family of Tumors or Desmoplastic Small Round-Cell Tumor

Official Title ^ICMJE

Phase II Trial of Gleevec (STI571) in Therapy of Ewing's Family of Tumors and Desmoplastic Small Round Cell Tumors

Brief Summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with recurrent Ewing's family of tumors or desmoplastic small round-cell tumor.

Detailed Description

OBJECTIVES:

Determine the effectiveness of imatinib mesylate in patients with recurrent Ewing's family of tumors or desmoplastic small round-cell tumor.
Determine the toxic effects of this drug in these patients.
Determine the duration of disease-free and overall survival of patients treated with this drug.

OUTLINE: This is an open-label study.

Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 28 days.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Sarcoma

Intervention ^ICMJE

Drug: imatinib mesylate

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

June 2007

Primary Completion Date

June 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Diagnosis of Ewing's family of tumors OR desmoplastic small round-cell tumor
Must have immunohistochemical evidence of expression of greater than 2+/4+ for either Kit (CD117) or platelet-derived growth factor receptor -a or -b
No symptomatic brain metastases
- Asymptomatic brain metastases are allowed provided patient is not on concurrent anticonvulsants or corticosteroids

PATIENT CHARACTERISTICS:

Age

Over 16

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count greater than 1,500/mm^3
Platelet count greater than 100,000/mm^3
Hemoglobin greater than 9 g/dL

Hepatic

Bilirubin less than 1.5 times upper limit of normal (ULN)
SGOT and SGPT less than 2.5 times ULN
No chronic active hepatitis
No cirrhosis
No other acute or known chronic liver disease

Renal

Creatinine less than 1.5 times ULN

Cardiovascular

No concurrent poorly controlled or severe cardiovascular disease

Pulmonary

No concurrent poorly controlled or severe pulmonary disease

Other

HIV negative
No concurrent poorly controlled or severe central nervous system disease
No other concurrent poorly controlled or severe nonmalignant disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

At least 3 weeks since prior chemotherapy

Endocrine therapy

See Disease Characteristics

Radiotherapy

At least 3 weeks since prior radiotherapy

Surgery

More than 2 weeks since prior major surgery

Other

More than 28 days since prior investigational agents

Sex/Gender

Sexes Eligible for Study:

All

Ages

16 Years and older (Child, Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00062205

Other Study ID Numbers ^ICMJE

CDR0000304551
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-IRB-02008

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Warren Chow MD, City of Hope Medical Center

Study Sponsor ^ICMJE

City of Hope Medical Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Not Provided

PRS Account

City of Hope Medical Center

Verification Date

February 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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