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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00062205
First received: June 5, 2003
Last updated: February 5, 2010
Last verified: February 2010

June 5, 2003
February 5, 2010
June 2002
June 2007   (final data collection date for primary outcome measure)
Response rate as measured by RECIST criteria [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00062205 on ClinicalTrials.gov Archive Site
Progression-free survival at 6 months [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Imatinib Mesylate in Treating Patients With Recurrent Ewing's Family of Tumors or Desmoplastic Small Round-Cell Tumor
Phase II Trial of Gleevec (STI571) in Therapy of Ewing's Family of Tumors and Desmoplastic Small Round Cell Tumors

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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Sarcoma
Drug: imatinib mesylate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2007
June 2007   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00062205
CDR0000304551, P30CA033572, CHNMC-IRB-02008
Not Provided
Warren Chow MD, City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Not Provided
City of Hope Medical Center
February 2010

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