- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00022048
Bevacizumab in Treating Patients With Myelodysplastic Syndrome
Safety and Efficacy Trial of Bevacizumab: Anti-VEGF Humanized Monoclonal Antibody (NSC 704865) Therapy for Myelodysplastic Syndrome (MDS)
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them.
PURPOSE: This phase I/II trial is to see if bevacizumab works in treating patients who have myelodysplastic syndrome.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
OBJECTIVES:
- Determine the hematologic responses, including changes in hemoglobin levels, neutrophil counts, platelet counts, and percentage of bone marrow blasts, in patients with myelodysplastic syndrome treated with bevacizumab.
- Determine the toxic effects of this regimen in these patients.
- Determine the tolerance in patients treated with this regimen.
- Determine bone marrow cytogenetic responses in patients treated with this regimen.
- Determine bone marrow microvessel density in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to International Prognostic Scoring System risk status (low (low or intermediate-1) vs high (intermediate-2 or high)).
Patients receive bevacizumab IV over 30-90 minutes. Treatment repeats every 2 weeks for 4-6 months in the absence of disease progression or unacceptable toxicity.
Patients are followed at weeks 1, 3, 5, 7, and 9.
PROJECTED ACCRUAL: A total of 16-25 patients will be accrued for this study within 2 years.
Type d'étude
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Lieux d'étude
-
-
Arizona
-
Tucson, Arizona, États-Unis, 85724
- Arizona Cancer Center at University of Arizona Health Sciences Center
-
-
California
-
Stanford, California, États-Unis, 94305-5750
- Stanford Cancer Center at Stanford University Medical Center
-
-
Texas
-
Houston, Texas, États-Unis, 77030-4009
- University of Texas - MD Anderson Cancer Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
DISEASE CHARACTERISTICS:
Histologically confirmed myelodysplastic syndrome (MDS)
- Refractory anemia (RA)
- RA with excess blasts (RAEB)
- RAEB in transformation
- RA with ringed sideroblasts
- Non-proliferative chronic myelomonocytic leukemia (WBC less than 12,000/mm^3)
At least 1 of the following cytopenias:
- Untransfused hemoglobin no greater than 10.0 g/dL and/or red cell transfusion dependent
- Absolute neutrophil count no greater than 1,800/mm^3 (neutropenia)
- Platelet count no greater than 100,000/mm^3 (thrombocytopenia)
- No secondary MDS
- No known brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
- Karnofsky 60-100%
Life expectancy:
- More than 4 months
Hematopoietic:
- See Disease Characteristics
- Platelet count at least 20,000/mm^3
- No hemorrhagic illness within the past 3 weeks
- No hemolysis
- No iron deficiency
- No active blood loss
Hepatic:
- AST and ALT no greater than 2.5 times upper limit of normal (ULN)
- Bilirubin no greater than 2.0 mg/dL
- INR less than 2.0
- PTT less than 1.5 times ULN
Renal:
- Creatinine no greater than 2.0 mg/dL
- No renal dysfunction requiring dialysis within the past 6 months
- No nephrotic syndrome within the past 6 months
Cardiovascular:
- No myocardial infraction within the past 6 months
- No severe or unstable angina within the past 6 months
- No severe peripheral vascular disease (ischemic rest pain, non-healing wound or ulcer, or tissue loss) within the past 6 months
- No uncontrolled hypertension within the past 6 months
- No transient ischemic attack within the past 6 months
- No cerebrovascular accident within the past 6 months
- No deep venous or arterial thrombosis
- No coronary artery disease
- No symptomatic congestive heart failure (New York Heart Association class II-IV heart disease)
- No cardiac arrhythmia
- No vascular illness within the past 3 weeks
Pulmonary:
- No pulmonary embolism
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
No other active malignancy except localized squamous cell or basal cell skin cancer
- Prior cured malignancy allowed
- No trauma within the past 3 weeks
- No significant inflammatory disease within the past 3 weeks
- No serious non-healing wound, ulcer, or bone fracture
- No hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
- No other active severe disease
- No infection
- No psychiatric illness or social situation that would preclude study compliance
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior allogeneic bone marrow transplantation
- At least 30 days since prior biologic response modifiers
- At least 30 days since prior hematopoietic growth factors
- At least 30 days since prior thalidomide
- No concurrent thalidomide
- No other concurrent biologic response modifiers
- No concurrent hematopoietic growth factors (including epoetin alfa)
- Concurrent filgrastim (G-CSF) for febrile neutropenia allowed
- Concurrent transfusions allowed
Chemotherapy:
- At least 30 days since prior chemotherapy
- No concurrent chemotherapy
Endocrine therapy:
- No concurrent corticosteroid therapy (more than 10 mg/day of prednisone or equivalent steroid dose) except for pre-medication for transfusions
Radiotherapy:
- At least 30 days since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- At least 3 weeks since prior surgery (including biopsy of visceral organ)
Other:
- At least 10 days since prior anticoagulants
- No concurrent cytotoxic agents
- No other concurrent investigational agents
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Peter L. Greenberg, MD, Stanford University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
- anémie réfractaire
- anémie réfractaire avec sidéroblastes en couronne
- anémie réfractaire avec excès de blastes
- anémie réfractaire avec excès de blastes en transformation
- leucémie myélomonocytaire chronique
- syndromes myélodysplasiques de novo
- syndromes myélodysplasiques précédemment traités
- tumeur myélodysplasique/myéloproliférative, inclassable
- leucémie myéloïde chronique atypique, BCR-ABL1 négatif
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Tumeurs par type histologique
- Tumeurs
- Maladie
- Maladies de la moelle osseuse
- Maladies hématologiques
- Conditions précancéreuses
- Syndrome
- Syndromes myélodysplasiques
- Leucémie
- Préleucémie
- Troubles myéloprolifératifs
- Maladies myélodysplasiques-myéloprolifératives
- Effets physiologiques des médicaments
- Agents antinéoplasiques
- Agents antinéoplasiques immunologiques
- Inhibiteurs de l'angiogenèse
- Agents modulateurs de l'angiogenèse
- Substances de croissance
- Inhibiteurs de croissance
- Bévacizumab
Autres numéros d'identification d'étude
- SUMC-MDA-ID-01152
- CDR0000068778 (Identificateur de registre: PDQ (Physician Data Query))
- MDA-ID-01152
- NCI-2771
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur bevacizumab
-
Dana-Farber Cancer InstituteBristol-Myers Squibb; Genentech, Inc.Complété
-
Koen RoversHoffmann-La Roche; Comprehensive Cancer Centre The Netherlands; Dutch Cancer...RecrutementCancer colorectal | Tumeurs péritonéales | Tumeur colorectale | Carcinose péritonéale | Carcinome colorectal | Cancer péritonéal | Métastases péritonéales | Adénocarcinome colorectal | Tumeurs colorectales malignes | Tumeur péritonéale Carcinomatose secondaire maligne | Tumeur péritonéale maligne secondairePays-Bas, Belgique
-
National Cancer Institute (NCI)Actif, ne recrute pasCarcinome récurrent des trompes de Fallope | Carcinome ovarien récurrent | Carcinome péritonéal primitif récurrent | Cystadénocarcinome à cellules claires de l'ovaire | Adénocarcinome endométrioïde ovarien | Cystadénocarcinome séreux ovarien | Adénocarcinome à cellules claires de l'endomètre | Adénocarcinome... et d'autres conditionsÉtats-Unis
-
Harbin Medical UniversitySun Yat-sen University; Fudan University; Cancer Institute and Hospital, Chinese... et autres collaborateursInconnueTumeurs colorectales | ChimiothérapieChine
-
Hoffmann-La RocheComplétéGlioblastome multiformeSuisse, France, Royaume-Uni, Danemark
-
Spanish Cooperative Group for the Treatment of...Roche Pharma AGComplété
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.ComplétéCancer du col de l'utérus | Glioblastome | Cancer des ovaires | Cancer du poumon | Cancer rectalChine
-
Azienda Ospedaliero, Universitaria PisanaComplété
-
National Taiwan University HospitalRésilié
-
National Cancer Institute (NCI)Actif, ne recrute pasMélanome cutané de stade IV AJCC v6 et v7 | Mélanome cutané de stade IIIC AJCC v7 | Mélanome non résécableÉtats-Unis