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

NCT00062205 | Completed Phase 2

• 3 other identifiers: CDR0000304551P30CA033572CHNMC-IRB-02008
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma

Keywords

recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor

Outcome Measures

Primary Outcomes (1)

• Response rate as measured by RECIST criteria

Secondary Outcomes (1)

• Progression-free survival at 6 months

Interventions

imatinib mesylate DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Sarcoma; Neuroectodermal Tumors, Primitive, Peripheral

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 5, 2003
• First Posted: June 6, 2003
• Study Start: June 1, 2002
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: February 9, 2010

Record last verified: 2010-02

Locations

US (1)