- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01300793
Study of Standard-Dose Rituximab, Ifosfamide, Carboplatin and Etoposide (V-RICE)
(RICE) Plus Bortezomib (Velcade) in a Dose-Escalating Fashion for Patients With Relapsed or Primary Refractory Aggressive B-Cell NHL
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Once subjects are determined to be eligible and informed consent is obtained,patients will be enrolled into a starting dose cohort of 1.0mg/m2. Based upon a satisfactory safety profile, additional patients will be enrolled into the 1.3, 1.5 and 1.7mg/m2 cohorts. Each of these dosing cohorts will only be enrolled if satisfactory safety profiles in each of the lower dosing cohorts are obtained. As the process continues, multiple cohorts will be receiving various dosing regimens simultaneously. If a DLT occurs in ≥2 out of 6 patients at the initial dose level, then 3 more patients will be accrued at dose level -1 (0.7mg/m2).
Bortezomib will be given on days 1 (prior to rituximab) and 4, rituximab 375 mg/m2 on day 1, carboplatin AUC 5 and ifosfamide with mesna, each 5 gm/m2, on day 3 and etoposide 100 mg/ m2/day on days 2, 3 and 4 of a 21-day cycle. They will also receive filgrastim on days 6-13 or pegfilgrastim on day 6. Dose-limiting toxicities (DLT) include any grade 3 or 4 non-hematologic toxicities (except alopecia and grade 3 febrile neutropenia), grade 4 febrile neutropenia (life-threatening sepsis) and grade 4 neutropenia persisting past day 35 or grade 3 or 4 thrombocytopenia persisting past day 35.
If there is a DLT at a given bortezomib dose level, 3 more subjects will be enrolled at that dose; if there are 2 or more DLTs then the MTD will be defined as the previous dose level. If at that dose level, >50% of subjects required bortezomib dose reduction, the MTD will be defined as the next lower dose level. Subjects will continue to be accrued in order to treat a minimum of 10 patients at the MTD.
Those who are candidates for autologous stem cell transplant will have CT scan of the neck, chest, abdomen and pelvis after 2 cycles. Subjects with PD or SD will be taken off study. Those with CR, PR or response not meeting PR criteria will undergo a total of 3 cycles of bortezomib + RICE. After the 3rd cycle of bortezomib + RICE, whole body PET/CT scan and bone marrow biopsy will be obtained.
Subjects who achieve CR or PR will then proceed to stem cell mobilization and collection by a standard regimen, followed by autologous stem cell transplant with a preparative regimen to be determined by the investigator. Those with SD or PD will be taken off study. While the mobilization and ASCT procedures are not part of the phase I protocol, outcomes of ASCT will be followed, including CD34+ progenitor cell collection, clinical response to transplant and survival.
Subjects who are not candidates for autologous stem cell transplant will have CT scan of the neck, chest, abdomen and pelvis after the 2nd and 4th cycles. Those who are responding will continue for a maximum of 6 cycles.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
California
-
San Francisco, California, Vereinigte Staaten, 94143
- Unviersity of California Medical Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
Aggressive B-cell non-Hodgkin lymphoma, CD-20 positive, in first relapse or refractory to first- or second-line chemotherapy (non-platinum)
- Diffuse large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma (Grade III), Transformed Follicular Lymphoma
- Prior Rituximab is allowed
- Prior radiation is allowed
- Prior autologous stem cell transplant is allowed
- Age 18-70 years
- ECOG performance status 0-2
- HIV seronegative
- No CNS involvement: CSF cytology is required for cases with bone marrow involvement, involvement of 2 or more extranodal sites, presentation in the testes or paranasal sinuses, or if any clinical suspicion of CNS involvement (e.g., cranial nerve deficits)
- Measurable disease on CT scan by international working group response criteria • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- Male subject agrees to use an acceptable method for contraception for the duration of the study.
Exclusion Criteria:
- Subject has a platelet count of less than 75,000.
- Subject has an absolute neutrophil count of less than 1000
- Subject has a calculated or measured creatinine clearance of <60 mL/minute within 14 days before enrollment.
- Subject has grade 2 or greater peripheral neuropathy or grade 1 with pain within 14 days before enrollment.
- Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
- Subject has hypersensitivity to bortezomib, boron or mannitol.
- Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Subject has been treated with more than two prior chemotherapy regimens
- Subject has been treated with a platinum-based regimen.
- Subject has received other investigational drugs with 14 days before enrollment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Determine the MTD of Velcade (bortezomib), Rituximab, Ifosfamide, Carboplatin, Etoposide (V-RICE) for patients with relapsed/primary refractory aggressive B-cell non-Hodgkin's lymphoma (NHL)
Zeitfenster: 5 years
|
5 years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
tolerability and safety, response rate, the amount of peripheral blood CD34+ progenitor cells collected and the rate of engraftment, assess the rate of autologous stem cell transplant
Zeitfenster: 5 years
|
5 years
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Lawrence Kaplan, M.D., University of California, San Francisco
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Immunsystems
- Neubildungen nach histologischem Typ
- Neubildungen
- Lymphoproliferative Erkrankungen
- Lymphatische Erkrankungen
- Immunproliferative Erkrankungen
- Lymphom
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antirheumatika
- Antineoplastische Mittel
- Immunologische Faktoren
- Antineoplastische Mittel, alkylierend
- Alkylierungsmittel
- Antineoplastische Mittel, Phytogen
- Topoisomerase-II-Inhibitoren
- Topoisomerase-Inhibitoren
- Antineoplastische Mittel, immunologische
- Carboplatin
- Etoposid
- Ifosfamid
- Isophosphamidsenf
- Rituximab
- Bortezomib
Andere Studien-ID-Nummern
- 06253
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur B-Zell-Lymphom
-
SWOG Cancer Research NetworkNational Cancer Institute (NCI); Genentech, Inc.RekrutierungDiffuses großzelliges B-Zell-Lymphom | Wiederkehrendes diffuses großzelliges B-Zell-Lymphom | Refraktäres diffuses großzelliges B-Zell-Lymphom | Primäres mediastinales (thymisches) großes B-Zell-Lymphom | Follikuläres Lymphom Grad 3b | Transformierte follikuläre Lymphe zu Diff Large B-Zell-Lymphom und andere BedingungenVereinigte Staaten
-
National Cancer Institute (NCI)AbgeschlossenAIDS-bedingtes peripheres/systemisches Lymphom | AIDS-assoziiertes diffuses großzelliges Lymphom | AIDS-bedingtes diffuses gemischtzelliges Lymphom | AIDS-bedingtes kleines Noncleaved-Cell-LymphomVereinigte Staaten
-
National Cancer Institute (NCI)AbgeschlossenAIDS-bedingtes peripheres/systemisches Lymphom | AIDS-assoziiertes diffuses großzelliges Lymphom | AIDS-bedingtes immunoblastisches großzelliges Lymphom | AIDS-bedingtes kleines Noncleaved-Cell-LymphomVereinigte Staaten
-
Bing HanAbgeschlossenPure Red Cell Aplasia, erworbenChina
-
Children's Oncology GroupNational Cancer Institute (NCI)AbgeschlossenDiffuses großzelliges Lymphom im Kindesalter | Immunoblastisches großzelliges Lymphom im Kindesalter | Burkitt-Lymphom im Kindesalter | Unbehandelte akute lymphoblastische Leukämie im Kindesalter | Stadium I des großzelligen Lymphoms im Kindesalter | Stadium I des kleinen, nicht gespaltenen... und andere BedingungenVereinigte Staaten
-
Johnson & Johnson Pharmaceutical Research & Development...Abgeschlossen
-
Peking Union Medical College HospitalUnbekannt
-
Johnson & Johnson Pharmaceutical Research & Development...AbgeschlossenReine Erythrozyten-AplasieVereinigtes Königreich, Schweden, Südafrika, Brasilien, Kanada, Deutschland, Norwegen, Thailand
-
Beijing Friendship HospitalBeijing Boren HospitalNoch keine RekrutierungLangerhans-Zell-HistiozytoseChina
Klinische Studien zur Velcade (bortezomib), rituximab, ifosfamide, carboplatin, etoposide
-
University of California, San FranciscoBeendetLymphom, B-ZellVereinigte Staaten
-
Memorial Sloan Kettering Cancer CenterColumbia University; Genentech, Inc.Abgeschlossen
-
Singapore General HospitalJanssen-Cilag Ltd.AbgeschlossenDiffuses großzelliges B-Zell-LymphomSingapur
-
University Hospital MuensterHannover Medical School; Deutsche Kinderkrebsstiftung; Gesellschaft fur Padiatrische...UnbekanntIntrakranielle KeimzelltumorenDeutschland
-
National Cancer Centre, SingaporeAbgeschlossenPeripheres T-Zell-LymphomSingapur
-
Memorial Sloan Kettering Cancer CenterAbgeschlossenLymphom | B-Zell-Non-Hodgkin-LymphomVereinigte Staaten
-
Beijing Tiantan HospitalRekrutierungIntrakranialer Keimzell-ZNS-Tumor, KindheitChina
-
National Cancer Centre, SingaporeGlaxoSmithKlineAbgeschlossenDiffuses großzelliges B-Zell-LymphomSingapur
-
Weill Medical College of Cornell UniversityMillennium Pharmaceuticals, Inc.Abgeschlossen
-
Antengene CorporationRekrutierungPeripheres T-Zell-Lymphom | NK/T-Zell-LymphomChina