- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00085111
Bevacizumab in Treating Young Patients With Refractory Solid Tumors
A Phase I Study of Bevacizumab in Refractory Solid Tumors
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
PRIMARY OBJECTIVES:
I. To estimate the maximum tolerable dose (MTD) of bevacizumab by dose escalation to a maximum of 15mg/kg, even if MTD is not reached, administered as an intravenous infusion, every 2 weeks to children with refractory solid tumors.
II. To determine the dose-limiting toxicities (DLT) and other toxicities of bevacizumab given on this schedule.
III. To characterize the pharmacokinetic behavior of bevacizumab in children with refractory cancer.
SECONDARY OBJECTIVES:
I. To preliminarily define the antitumor activity of bevacizumab within the confines of a phase I study.
II. To assess the biologic activity of bevacizumab by measuring levels of total serum VEGF, and parallel angiogenic markers V-CAM-1, ICAM-1, bFGF, and TSP-1 at baseline and at time points post therapy.
III. To explore the biologic effect of bevacizumab on circulating endothelial cells (CECs) and circulating endothelial cell precursors (CECPs).
IV. To determine in archival tumor tissue the expression of VEGF by immunohistochemistry and/or real time PCR.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bevacizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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California
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Arcadia, California, États-Unis, 91006-3776
- COG Phase I Consortium
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Histologically confirmed solid tumor at original diagnosis
- Measurable or evaluable* disease
- No known curative therapy exists
- No lymphomas or primary CNS tumors
- No history or clinical evidence of CNS metastasis by head CT scan
- Performance status - Karnofsky 50-100% (patients > 10 years of age)
- Performance status - Lansky 50-100% (patients ≤ 10 years of age)
- At least 8 weeks
Patients without bone marrow involvement:
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 100,000/mm^3 (transfusion independent)
- Hemoglobin ≥ 8.0 g/dL (RBC transfusion allowed)
Patients with bone marrow metastases:
- Platelet count ≥ 75,000/mm^3 (transfusion independent)
- Granulocytopenia, anemia, and/or mild thrombocytopenia allowed
- No known bleeding diathesis or coagulopathy
- No known thrombophilic condition (e.g., protein S, protein C, or antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation, homocystinemia, or antiphospholipid antibody syndrome)
- PT or PTT ≤ 1.2 times upper limit of normal (ULN)
- ALT ≤ 5 times ULN
- Bilirubin ≤ 1.5 times ULN
- Albumin ≥ 2 g/dL
- Creatinine clearance or radioisotope glomerular filtrationrate ≥ 70 mL/min
Creatinine based on age as follows:
- Creatinine ≤ 0.8 mg/dL (patients ≤ 5 years of age)
- Creatinine ≤ 1.0 mg/dL (patients 6 to 10 years of age)
- Creatinine ≤ 1.2 mg/dL (patients 11 to 15 years of age)
- Creatinine ≤ 1.5 mg/dL (patients > 15 years of age)
- No proteinuria
- 24-hour urine protein ≤ 500 mg
- No history of stroke
- No deep venous or arterial thrombosis within the past 3 months
No uncontrolled hypertension
- Hypertension must be well-controlled with stable doses of medication for at least 2 weeks
- No history of myocardial infarction
- No severe or unstable angina
- No transient ischemic attack within the past 6 months
- No cerebrovascular accident within the past 6 months
- No other arterial thromboembolic event within the past 6 months
- No clinically significant or severe peripheral vascular disease
- No pulmonary embolism within the past 3 months
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after study participation
- No chronic non-healing wound, ulcer, or bone fracture
- No significant traumatic injury within the past 28 days
- No uncontrolled seizures
- No uncontrolled infection
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- Recovered from prior immunotherapy
- More than 1 week since prior growth factors
At least 2 months since prior stem cell transplantation
- No evidence of active graft-vs-host disease
- At least 8 weeks since prior monoclonal antibody therapy
- At least 7 days since prior antineoplastic biologic agents
- No prior bevacizumab
- No concurrent prophylactic growth factors
- No other concurrent immunotherapy or biologic therapy
- More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered
- No concurrent chemotherapy
- Recovered from prior radiotherapy
- At least 4 months since prior craniospinal radiotherapy
- At least 4 months since prior radiotherapy to ≥ 50% of the pelvis
- At least 6 weeks since other prior substantial bone marrow radiotherapy
- At least 2 weeks since prior local palliative small-port radiotherapy
- No concurrent radiotherapy
- More than 28 days since prior major surgery
- At least 7 days since prior minor surgery (for limited purposes of tissue retrieval) and recovered
- At least 24 hours since prior placement of an indwelling IV catheter
At least 1 week since prior full-dose anticoagulation therapy, including systemic thrombolytic agents, heparin, low-molecular weight heparin, and warfarin
- Local intralumenal anticoagulants (e.g., heparin or tissue plasminogen activator) allowed to maintain patency of preexisting, permanent, indwelling IV catheters or peripheral IV catheters for blood sampling
- More than 1 week since prior antipyretic and anti-inflammatory medications (except acetaminophen)
- No concurrent full-dose anticoagulation therapy
- No concurrent anti-inflammatory medication
- Concurrent acetaminophen allowed
- No other concurrent cancer therapy
- No other concurrent investigational agents
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Arm I
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15.
Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
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Étant donné IV
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Maximum tolerated dose defined based on the dose-limiting toxicities graded according to Common Terminology Criteria for Adverse Events v3.0
Délai: 28 days
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28 days
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Julia Bender, COG Phase I Consortium
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (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
Termes MeSH pertinents supplémentaires
- Tumeurs
- Effets physiologiques des médicaments
- Agents antinéoplasiques
- Facteurs immunologiques
- Inhibiteurs de l'angiogenèse
- Agents modulateurs de l'angiogenèse
- Substances de croissance
- Inhibiteurs de croissance
- Anticorps
- Immunoglobulines
- Bévacizumab
- Anticorps monoclonaux
- Agents antinéoplasiques immunologiques
Autres numéros d'identification d'étude
- NCI-2012-01813
- U01CA097452 (Subvention/contrat des NIH des États-Unis)
- ADVL0314
- COG-ADVL0314
- CDR0000367299
- NCI-04-C-0148
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 .
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