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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00062205
Enrollment
40
Registered
2003-06-06
Start date
2002-06-30
Completion date
2007-06-30
Last updated
2010-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma

Keywords

recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor

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.

Interventions

DRUGimatinib mesylate

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
City of Hope Medical Center
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Response rate as measured by RECIST criteria

Secondary

MeasureTime frame
Progression-free survival at 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026