- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00002676
Chemotherapy and Whole-Brain Radiation Therapy in Treating Patients With Primary Central Nervous System Non- Hodgkin's Lymphoma
PHASE II TRIAL OF CHEMOTHERAPY PLUS RADIOTHERAPY FOR MANAGEMENT OF PRIMARY CENTRAL NERVOUS SYSTEM NON-HODGKIN'S LYMPHOMA (PCNSL)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells and may be an effective treatment for non-Hodgkin's lymphoma.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and whole-brain radiation therapy in patients with primary central nervous system non-Hodgkin's lymphoma.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Arizona
-
Scottsdale, Arizona, Forenede Stater, 85259-5404
- CCOP - Scottsdale Oncology Program
-
-
Colorado
-
Denver, Colorado, Forenede Stater, 80209-5031
- CCOP - Colorado Cancer Research Program, Inc.
-
-
Illinois
-
Peoria, Illinois, Forenede Stater, 61602
- CCOP - Illinois Oncology Research Association
-
Urbana, Illinois, Forenede Stater, 61801
- CCOP - Carle Cancer Center
-
-
Iowa
-
Cedar Rapids, Iowa, Forenede Stater, 52403-1206
- CCOP - Cedar Rapids Oncology Project
-
Des Moines, Iowa, Forenede Stater, 50309-1016
- CCOP - Iowa Oncology Research Association
-
Sioux City, Iowa, Forenede Stater, 51101-1733
- Siouxland Hematology-Oncology
-
-
Kansas
-
Wichita, Kansas, Forenede Stater, 67214-3882
- CCOP - Wichita
-
-
Louisiana
-
New Orleans, Louisiana, Forenede Stater, 70121
- CCOP - Ochsner
-
-
Michigan
-
Kalamazoo, Michigan, Forenede Stater, 49007-3731
- CCOP - Kalamazoo
-
-
Minnesota
-
Duluth, Minnesota, Forenede Stater, 55805
- CCOP - Duluth
-
Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
-
Saint Louis Park, Minnesota, Forenede Stater, 55416
- CCOP - Metro-Minnesota
-
-
Nebraska
-
Omaha, Nebraska, Forenede Stater, 68131
- CCOP - Missouri Valley Cancer Consortium
-
-
New Jersey
-
Hackensack, New Jersey, Forenede Stater, 07601
- CCOP - Northern New Jersey
-
-
North Dakota
-
Bismarck, North Dakota, Forenede Stater, 58501
- Quain & Ramstad Clinic, P.C.
-
Grand Forks, North Dakota, Forenede Stater, 58201
- Altru Health Systems
-
-
Ohio
-
Columbus, Ohio, Forenede Stater, 43206
- CCOP - Columbus
-
Toledo, Ohio, Forenede Stater, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
-
-
South Dakota
-
Rapid City, South Dakota, Forenede Stater, 57709
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Forenede Stater, 57105-1080
- CCOP - Sioux Community Cancer Consortium
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS: Primary central nervous system non-Hodgkin's lymphoma (PCNSL) Clinically diagnosed intracranial space-occupying lesion Pathology consistent with non-Hodgkin's lymphoma and reviewed by NCCTG Biopsy optional if characteristic history, pathognomonic neuroimaging, and cytology are consistent with malignant lymphocytes from vitrectomy, CSF, or both No occult systemic lymphoma or prior lymphoma No post-transplant lymphoproliferative disorder Disease measurable or evaluable on postoperative contrast-enhanced CT or MRI Postoperative therapy must start within 6 weeks of definitive diagnosis
PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: ECOG 0-3 Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 120,000/mm3 Hepatic: Bilirubin no greater than 2 times normal AST no greater than 2 times normal Renal: Creatinine no greater than 1.5 times normal Cardiovascular: No heart failure No uncontrolled arrhythmia Pulmonary: No severe pulmonary failure Other: No serious uncontrolled infection No active bleeding No AIDS or HIV-positive serology No prior organ transplant No pregnant or nursing women Negative pregnancy test required of fertile women Adequate contraception required of fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Corticosteroids allowed if dose fixed or decreasing for at least 1 week prior to baseline scan Radiotherapy: No prior radiotherapy Surgery: Not specified
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: CHOD + BVAM + WBRT
Patients 70 years old and younger with newly diagnosed, biopsy-proven PCNSL received one cycle of CHOD followed by two cycles of BVAM.
Patients then received WBRT, 30.6 Gy, if a complete response was evoked, or 50.4 Gy if the response was less than complete; both doses were given in 1.8-Gy daily fractions.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Response rate
Tidsramme: Up to 10 years
|
Up to 10 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Samlet overlevelse
Tidsramme: Op til 10 år
|
Op til 10 år
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Brian P. O'Neill, MD, Mayo Clinic
Publikationer og nyttige links
Generelle publikationer
- Laack NN, O'Neill BP, Ballman KV, O'Fallon JR, Carrero XW, Kurtin PJ, Scheithauer BW, Brown PD, Habermann TM, Colgan JP, Gilbert MR, Hawkins RB, Morton RF, Windschitl HE, Fitch TR, Pajon ER Jr; North Central Cancer Treatment Group and Mayo Clinic. CHOD/BVAM chemotherapy and whole-brain radiotherapy for newly diagnosed primary central nervous system lymphoma. Int J Radiat Oncol Biol Phys. 2011 Oct 1;81(2):476-82. doi: 10.1016/j.ijrobp.2010.06.002. Epub 2010 Aug 26.
- O'Neill BP, O'Fallon JR, Cha SS, et al.: Newly diagnosed primary central nervous system lymphoma (PCNSL): initial report of North Central Cancer Treatment Group (NCCTG)/Eastern Cooperative Oncology Group (ECOG) protocol 93 73 51. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2074, 2002.
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
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesygdomme
- Immunproliferative lidelser
- Lymfom
- Lymfom, Non-Hodgkin
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Autonome agenter
- Agenter fra det perifere nervesystem
- Antivirale midler
- Nukleinsyresyntesehæmmere
- Enzymhæmmere
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antiemetika
- Gastrointestinale midler
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Antineoplastiske midler, fytogene
- Topoisomerase II-hæmmere
- Topoisomerasehæmmere
- Dermatologiske midler
- Sporelementer
- Mikronæringsstoffer
- Antibiotika, antineoplastisk
- Reproduktive kontrolmidler
- Abortfremkaldende midler, ikke-steroide
- Aborterende midler
- Folinsyreantagonister
- Dexamethason
- Cyclofosfamid
- Doxorubicin
- Liposomal doxorubicin
- Cytarabin
- Methotrexat
- Vincristine
- Carmustine
- Kobolt
Andre undersøgelses-id-numre
- NCCTG-937351
- E-N9371
- CDR0000064319 (Registry Identifier: PDQ (Physician Data Query))
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 cyclophosphamid
-
Children's Hospital Los AngelesLucile Packard Children's HospitalAfsluttetMetaboliske sygdomme | Stamcelletransplantation | Kronisk granulomatøs sygdom | Knoglemarvstransplantation | Thalassæmi | Wiskott-Aldrich syndrom | Genetiske sygdomme | Perifer blodstamcelletransplantation | Pædiatri | Diamond-Blackfan Anæmi | Allogen Transplantation | Kombineret immundefekt | X-bundet lymfoproliferativ...
-
Medical College of WisconsinNational Cancer Institute (NCI); National Heart, Lung, and Blood Institute... og andre samarbejdspartnereAfsluttetAnæmi, aplastiskForenede Stater
-
Centre Oscar LambretAfsluttet
-
Institut BergoniéMerck Sharp & Dohme LLC; National Cancer Institute, France; Transgene; Fondation...RekrutteringBrystkræft | Blødt væv sarkom | Faste tumorerFrankrig
-
Columbia UniversityUkendtAlvorlig kombineret immundefekt | Fanconi Anæmi | Knoglemarvssvigt | OsteopetroseForenede Stater
-
Shandong Cancer Hospital and InstituteUkendt
-
Mahidol UniversityAfsluttetNyreinsufficiens | InfektionThailand
-
National Cancer Institute, NaplesImmatics Biotechnologies GmbH; CureVac; European Commission -FP7-Health-2013-Innovation-1AfsluttetHepatocellulært karcinomBelgien, Tyskland, Italien, Spanien, Det Forenede Kongerige
-
University of Turin, ItalyUkendt
-
Tao OUYANGAfsluttet