Clinical trial NCT00062205: Imatinib Mesylate in Treating Patients With Recurrent Ewing's Family of Tumors or Desmoplastic Small Round-Cell Tumor
Official title: Phase II Trial of Gleevec (STI571) in Therapy of Ewing's Family of Tumors and Desmoplastic Small Round Cell Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcoma
Keywords: recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-06-06
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Response rate as measured by RECIST criteria
Secondary outcomes:
measure: Progression-free survival at 6 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
Study officials:
References: