- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00062205
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
California
-
Duarte, California, Forenede Stater, 91010-3000
- City of Hope Comprehensive Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
|---|
|
Responsrate målt ved RECIST-kriterier
|
Sekundære resultatmål
Resultatmål |
|---|
|
Progressionsfri overlevelse ved 6 måneder
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer, bindevæv og blødt væv
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer, kirtel og epitel
- Neoplasmer, Neuroepithelial
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Osteosarkom
- Neoplasmer, Knoglevæv
- Neoplasmer, bindevæv
- Neuroektodermale tumorer, primitive
- Sarkom
- Sarkom, Ewing
- Neuroektodermale tumorer, primitive, perifere
- Desmoplastisk lille rundcellet tumor
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Proteinkinasehæmmere
- Imatinib mesylat
Andre undersøgelses-id-numre
- CDR0000304551
- P30CA033572 (U.S. NIH-bevilling/kontrakt)
- CHNMC-IRB-02008
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .