- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00165477
Study of Lenalidomide and XRT in Patients With Newly Diagnosed Glioblastoma Multiforme
8. marts 2010 opdateret af: Dana-Farber Cancer Institute
Phase II Study of Lenalidomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme.
- The purpose of this study is to find out if the combination of lenalidomide and radiation therapy is effective in controlling tumor growth in patients with newly-diagnosed supratentorial glioblastoma or gliosarcoma.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
- Patients will receive lenalidomide orally once daily for 21 days followed by a one week rest period (this is equivalent to one cycle).
- Four to seven days from the first dose of lenalidomide, the patient will start radiation therapy for approximately 6-7 weeks.
- A neurologic exam and routine blood tests will be performed weekly while the patient is receiving radiation therapy.
- Following the 11th week of treatment a MRI/CT scan will be performed to assess the status of the tumor. If there is no change, or there is shrinkage in the size of the tumor, the treatment will continue for another 4 week cycle.
- The four week cycle will continue as long as the disease remains stable or improved and the patient does not develop intolerable side effects. A MRI/CT scan will be done every 2 cycles (8 weeks).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
23
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02115
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
-
Boston, Massachusetts, Forenede Stater, 02115
- Beth Israel Deaconess Medical Center
-
-
Virginia
-
Charlottesville, Virginia, Forenede Stater, 22908-0394
- University of Virginia
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients with histologically confirmed newly-diagnosed supratentorial glioblastoma multiforme (GBM) or gliosarcoma will be eligible for this protocol.
- The patient must have recovered from the effects of surgery, post-operative infections and other complications before entry into the study.
- Diagnosis will have been established by biopsy or resection no more than 28 days prior to registration.
- If tumor resection or open biopsy was performed, cranial MRI or contrast CT must have been performed before and after surgery. Imaging within 96 h of surgery is preferred but not required.
- If needle biopsy (stereotactic) was performed, gadolinium MRI or contrast CT within 14 days prior to registration is required. A post-operative scan is not required. The use of MRI rather than CT is preferred. The same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for tumor measurement. Patients without measurable or assessable disease are eligible.
- Patients receiving steroids must be on stable or decreasing doses for at least 5 days prior to entry.
- Patients must have a plan to begin partial brain radiotherapy 4-7 days after beginning lenalidomide, and within 35 days of the surgical procedure that established the diagnosis.
- Radiotherapy must be at the Radiation Oncology Department of the registered institution.
- Patients must be willing to forego cytotoxic and non-cytotoxic drug therapy against the tumor while being treated with lenalidomide.
- All patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
- Patients must be > 18 years old, and with a life expectancy > 8 weeks.
- Patients must have a Karnofsky performance status of > 60.
- Patients must have adequate bone marrow, liver, and renal function.
- Patients must be willing and able to comply with all study requirements
Exclusion Criteria:
- Patient must not have had prior cranial radiation therapy.
- Patients must not have received prior cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy for brain tumors. Patients who received Gliadel wafers will be excluded.
- Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patients ability to tolerate this therapy.
- Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible.
- Patients must not have active infection.
- Patients must not be pregnant/breast feeding and must agree to practice adequate contraception.
- Patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism.
- Patients must not have serious concurrent medical illness.
- Patient with recent thromboembolic disease (deep vein thrombosis and pulmonary embolism) are eligible if they are clinically stable and the thromboembolic event occurred more than 2 weeks prior to enrollment into this protocol.
- Patients must not have metastases below the tentorium or beyond the cranial vault.
- Patients must not have a known diagnosis of HIV, active infectious hepatitis, or chronic hepatitis.
- Patients must have no history of hypersensitivity or development of a desquamating rash while on thalidomide.
- Patients must have no prior exposure to lenalidomide.
- Previous or planned stereotactic radiosurgery or brachytherapy.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
To determine the efficacy of lenalidomide with conventional radiation therapy in the treatment of patients with newly-diagnosed supratentorial glioblastoma or gliosarcoma.
Tidsramme: 3 years
|
3 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
To assess the proportion of patients treated with lenalidomide and radiation therapy surviving at 12 months
Tidsramme: 3 years
|
3 years
|
to evaluate the time to tumor progression
Tidsramme: 3 years
|
3 years
|
the radiologic response
Tidsramme: 3 years
|
3 years
|
to determine the safety and toxicity of the combination of lenalidomide and radiation therapy.
Tidsramme: 3 years
|
3 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Patrick Y. Wen, MD, Dana-Farber Cancer Institute
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2005
Primær færdiggørelse (Faktiske)
1. november 2007
Studieafslutning (Faktiske)
1. juli 2009
Datoer for studieregistrering
Først indsendt
9. september 2005
Først indsendt, der opfyldte QC-kriterier
9. september 2005
Først opslået (Skøn)
14. september 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
10. marts 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. marts 2010
Sidst verificeret
1. marts 2010
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer, kirtel og epitel
- Astrocytom
- Neoplasmer, Neuroepithelial
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Glioblastom
- Gliom
- Gliosarkom
- Lægemidlers fysiologiske virkninger
- Antineoplastiske midler
- Immunologiske faktorer
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Lenalidomid
Andre undersøgelses-id-numre
- 05-222
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 .
Kliniske forsøg med Glioblastom
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Milton S. Hershey Medical CenterRekrutteringGlioblastom | Glioblastoma Multiforme | Glioblastoma Multiforme, voksen | Glioblastoma Multiforme i hjernenForenede Stater
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Milton S. Hershey Medical CenterNational Cancer Institute (NCI)RekrutteringGlioblastom | Glioblastoma Multiforme | Glioblastoma Multiforme, voksen | Glioblastoma Multiforme i hjernenForenede Stater
-
Jasper GerritsenMassachusetts General Hospital; Universitaire Ziekenhuizen KU Leuven; University... og andre samarbejdspartnereRekrutteringGlioblastom | Glioblastoma Multiforme | Glioblastom, IDH-vildtype | Glioblastoma Multiforme, voksen | Glioblastoma Multiforme i hjernenForenede Stater, Belgien, Schweiz, Tyskland, Holland
-
University of UtahTrukket tilbageGlioblastoma Multiforme (GBM)Forenede Stater
-
TVAX BiomedicalFDA Office of Orphan Products DevelopmentRekrutteringGlioblastoma Multiforme i hjernenForenede Stater
-
Shenzhen Geno-Immune Medical InstituteTilmelding efter invitationGlioblastoma Multiforme | Glioblastoma Multiforme i hjernenKina
-
University of Roma La SapienzaAfsluttetGlioblastoma Multiforme i hjernen
-
Imperial College LondonRekrutteringGlioblastoma Multiforme i hjernenDet Forenede Kongerige
-
Clinique Neuro-OutaouaisAfsluttetGlioblastoma Multiforme i hjernenCanada
-
Sunnybrook Health Sciences CentreRekrutteringGlioblastoma Multiforme, voksenCanada
Kliniske forsøg med lenalidomide
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Sidney Kimmel Comprehensive Cancer Center at Johns...AfsluttetMyelodysplastisk syndromForenede Stater
-
Celgene CorporationICON Clinical ResearchAfsluttetMyelodysplastiske syndromerTyskland, Israel, Det Forenede Kongerige, Spanien, Belgien, Italien, Frankrig, Holland, Sverige
-
Grupo Español de Linfomas y Transplante Autólogo...Celgene Corporation; Dynamic Science S.L.; Thermo Fisher Scientific, IncAfsluttetDiffust storcellet B-celle lymfomSpanien
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Boston VA Research Institute, Inc.Celgene Corporation; Edward Hines Jr. VA Hospital; Michael E. DeBakey VA... og andre samarbejdspartnereAfsluttet
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Swiss Group for Clinical Cancer ResearchAfsluttetLymfomSchweiz, Norge, Sverige
-
Groupe Francophone des MyelodysplasiesUkendtMyelodysplastiske syndromerFrankrig
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Dana-Farber Cancer InstituteBeth Israel Deaconess Medical Center; Genentech, Inc.; Brigham and Women's... og andre samarbejdspartnereAfsluttetWaldenstroms makroglobulinæmiForenede Stater
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Samsung Medical CenterRekrutteringRecidiverende og/eller refraktær non-Hodgkin T-celle lymfomKorea, Republikken
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CelgeneAfsluttetMantelcellelymfomForenede Stater, Frankrig, Belgien, Østrig, Israel, Singapore, Spanien, Det Forenede Kongerige, Ungarn, Colombia, Tyskland, Italien, Kalkun, Puerto Rico