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


Phase 2
16 Years
N/A
Not Enrolling
Both
Sarcoma

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate as measured by RECIST criteria

Safety Issue:

No

Authority:

United States: Federal Government

Study ID:

CDR0000304551

NCT ID:

NCT00062205

Start Date:

June 2002

Completion Date:

June 2007

Related Keywords:

  • Sarcoma
  • recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • Desmoplastic Small Round Cell Tumor
  • Sarcoma, Ewing's
  • Sarcoma

Name

Location

City of Hope Comprehensive Cancer CenterDuarte, California  91010