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

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00062205
• Other study ID #: CDR0000304551
• Secondary ID: P30CA033572CHNMC
• Status: Completed
• Phase: Phase 2
• First received: June 5, 2003
• Last updated: February 5, 2010
• Start date: June 2002
• Est. completion date: June 2007

Study information

• Verified date: February 2010
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Desmoplastic Small Round Cell Tumor
• Sarcoma
• Sarcoma, Ewing

Intervention

Drug:
• imatinib mesylate

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate as measured by RECIST criteria			No
Secondary	Progression-free survival at 6 months			No