- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00000801
Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma
To estimate the response rate, overall and disease-free survival, toxicities, factors associated with outcome, and effect on quality of life in patients with AIDS-related primary CNS lymphoma treated with CHOD (cyclophosphamide, doxorubicin, vincristine, and dexamethasone) plus filgrastim (granulocyte-colony stimulating factor; G-CSF) and external beam irradiation. To determine other clinical markers present in this patient population.
Combined modality therapy may prove of benefit for patients with AIDS-related primary CNS lymphoma.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Combined modality therapy may prove of benefit for patients with AIDS-related primary CNS lymphoma.
Patients who upon staging workup are found to be without systemic involvement undergo one cycle of chemotherapy with cyclophosphamide, doxorubicin, vincristine, dexamethasone, and G-CSF. Cyclophosphamide, doxorubicin, and vincristine are administered intravenously on day 1. Dexamethasone is administered intravenously on day 1 and then orally thereafter with gradual discontinuation. G-CSF is administered subcutaneously daily beginning on day 2 and continuing for a total of 10 days or until blood counts have recovered to an acceptable level. Patients with evidence of cancer cells in their cerebrospinal fluid (CSF) will receive chemotherapy with intrathecal cytarabine twice weekly until no further evidence of cancer cells is found in the CSF, then once weekly for 6 weeks, and then monthly for 10 months. Seven to ten days following completion of one cycle of chemotherapy, patients undergo radiotherapy to the brain at a dose of 2.5 Gy daily for 5 days per week for approximately 4 weeks. Total dose to the whole brain and meninges is 30.0 Gy in 12 fractions, and total dose to the primary boost volume is 10.0 Gy in 4 fractions. During therapy, blood is drawn weekly and brain scans are performed every 3-12 weeks. An initial CSF sample will be obtained by lumbar puncture.
Undersøgelsestype
Tilmelding
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
California
-
San Francisco, California, Forenede Stater, 941102859
- San Francisco AIDS Clinic / San Francisco Gen Hosp
-
San Francisco, California, Forenede Stater, 941102859
- San Francisco Gen Hosp
-
-
Colorado
-
Denver, Colorado, Forenede Stater, 80262
- Univ of Colorado Health Sciences Ctr
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02215
- Beth Israel Deaconess - West Campus
-
Brookline, Massachusetts, Forenede Stater, 02146
- ECOG Data Management Office
-
-
New York
-
New York, New York, Forenede Stater, 10029
- Mount Sinai Med Ctr
-
-
South Carolina
-
West Columbia, South Carolina, Forenede Stater, 29169
- Julio Arroyo
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria
Concurrent Medication: Required:
- PCP prophylaxis with Bactrim, dapsone, or aerosolized pentamidine.
- Oral candidiasis prophylaxis with fluconazole, ketoconazole, or clotrimazole oral troches.
- Antiretroviral agent available by therapy IND.
- MAI prophylaxis with rifabutin (in patients with CD4 counts < 100 cells/mm3).
Patients must have:
- HIV infection.
- Primary CNS lymphoma with NO systemic involvement.
Prior Medication:
Allowed:
- Prior corticosteroids.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Concomitant malignancy other than Kaposi's sarcoma, curatively treated carcinoma in situ of the cervix, or squamous or basal cell carcinoma of the skin.
- Active uncontrolled infection.
- Renal failure, active nonmalignant duodenal ulcer, uncontrolled diabetes mellitus, or other serious medical conditions that would preclude aggressive cytotoxic chemotherapy administration.
- Active heart disease (congestive heart failure or heart block greater than first degree on EKG).
Concurrent Medication:
Excluded:
- Any investigational agent other than antiretroviral agents available by therapy IND.
Patients with the following prior conditions are excluded:
- No prior malignancy other than Kaposi's sarcoma, curatively treated carcinoma in situ of the cervix, or squamous cell or basal cell carcinoma of the skin.
- No new infectious complications within the past 2 weeks that require a change in antibiotics.
- History of myocardial infarction within the past 3 months.
Prior Medication:
Excluded:
- Prior chemotherapy other than for Kaposi's sarcoma.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Krigel RL
- Studiestol: Von Roenn J
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
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 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
- 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
- Antibiotika, antineoplastisk
- Dexamethason
- Cyclofosfamid
- Doxorubicin
- Liposomal doxorubicin
- Cytarabin
- Vincristine
Andre undersøgelses-id-numre
- ACTG 252
- ECOG E 1493
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 HIV-infektioner
-
University of Santiago de CompostelaOsteology FoundationRekruttering
-
Institut PasteurRekruttering
-
Universidad del DesarrolloAfsluttetHealthcare Associated InfectionChile
-
The University of Texas Health Science Center,...EurofinsAfsluttetOdontogen Deep Space Neck InfectionForenede Stater
-
Imelda Hospital, BonheidenAfsluttetHealthcare Associated InfectionBelgien
-
University of PennsylvaniaAfsluttetAntimikrobiel resistensForenede Stater, Botswana
-
University of Maryland, BaltimoreVA Office of Research and DevelopmentAfsluttetMenneskelig mikrobiomForenede Stater
-
Universidad Autonoma de Nuevo LeonUkendtSundhedsrelaterede infektioner
-
Centre Hospitalier Universitaire de NīmesRekrutteringÆldre | Healthcare Associated InfectionFrankrig
-
Centre Hospitalier Universitaire, AmiensAfsluttetHealthcare Associated Infection | IglerFrankrig
Kliniske forsøg med Filgrastim
-
Sidney Kimmel Cancer Center at Thomas Jefferson...AfsluttetNon-Hodgkins lymfom | PlasmacellemyelomForenede Stater
-
Medical University of BialystokUkendtØg muskelstyrken hos patienter med muskelsvindPolen
-
National Cancer Institute (NCI)AfsluttetRhabdomyosarkom | Synovialt sarkom | Ewings sarkom | MPNST | Højrisiko sarkomForenede Stater
-
Franziska WachterHarvard Clinical and Translational Science Center (Harvard Catalyst)RekrutteringAkut myeloid leukæmi | Myelodysplastiske syndromer | MDS | Aml | Myeloid neoplasma | Myeloide maligniteter | Arveligt knoglemarvssvigtsyndromForenede Stater
-
PfizerHospira, now a wholly owned subsidiary of PfizerAfsluttetIkke-metastaserende brystkræftUngarn, Spanien
-
Eurofarma Laboratorios S.A.AfsluttetNeutropeni i brystkræftBrasilien
-
Trio FertilityRekrutteringPrimær ovarieinsufficiens | For tidlig ovariesvigtCanada
-
Ottawa Hospital Research InstituteAfsluttetBrystkræft i tidligt stadiumCanada
-
PfizerAfsluttet
-
Seoul St. Mary's HospitalUkendtLeukæmi, Myeloid, AkutKorea, Republikken