- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00016991
ZD 1839 in Treating Patients With Glioblastoma Multiforme in First Relapse
A Phase II Study of ZD 1839 (NSC 715055) for Patients With First Relapse Glioblastoma Multiforme
RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of glioblastoma multiforme.
PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have glioblastoma multiforme in first relapse.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
- Determine the activity of ZD 1839 in patients with glioblastoma multiforme in first relapse.
- Determine the pharmacokinetics and toxicity of this drug in these patients.
- Assess the relationship between epidermal growth factor receptor status in these patients and activity of this drug.
OUTLINE: Patients receive oral ZD 1839 once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed for at least 6 months.
PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study within 12-18 months.
Undersøgelsestype
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
North Carolina
-
Durham, North Carolina, Forenede Stater, 27710
- Duke Comprehensive Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
- Histologically confirmed glioblastoma multiforme in first relapse
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- More than 12 weeks
Hematopoietic:
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- AST/ALT no greater than 2.5 times ULN
Renal:
- Creatinine less than 1.5 times ULN
Cardiovascular:
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other:
- No other uncontrolled concurrent illness
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No prior allergic reactions to compounds of similar chemical or biologic composition to ZD 1839
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Ocular inflammation must be fully treated before study entry
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
Endocrine therapy:
- Must be on stable dose of steroids for at least 1 week
Radiotherapy:
- At least 4 weeks since prior radiotherapy and recovered
Surgery:
- At least 1 week since prior surgery
Other:
- No other concurrent investigational agents
- No other concurrent anticancer therapy
- No concurrent combination antiretroviral therapy for HIV
- No concurrent enzyme-inducing anticonvulsant drugs
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Henry S. Friedman, MD, Duke University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse
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
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i nervesystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Neoplasmer, kirtel og epitel
- Astrocytom
- Gliom
- Neoplasmer, Neuroepithelial
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Glioblastom
- Neoplasmer i nervesystemet
- Neoplasmer i centralnervesystemet
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Proteinkinasehæmmere
- Gefitinib
Andre undersøgelses-id-numre
- 2421
- DUMC-2421-03-2R2
- DUMC-2421-01-2
- NCI-1253
- CDR0000068639 (Anden identifikator: NCI)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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