- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00054405
Interleukin-12 and Interleukin-2 in Treating Patients With Refractory or Recurrent Neuroblastoma
A Phase I Investigation of IL-12 (NSC 672423)/Pulse IL-2 (Aldesleukin) in Children With Persistent and/or Refractory Neuroblastoma (13623)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES:
I. Define the maximum tolerated dose and dose-limiting toxicity of interleukin-12 with or without interleukin-2 in patients with refractory or recurrent neuroblastoma.
II. Determine, preliminarily, the antitumor effect of interleukin-12 with or without interleukin-2 in these patients.
III. Evaluate the immunoregulatory activity of interleukin-12 with or without interleukin-2 in these patients.
IV. Evaluate the antiangiogenic activity of interleukin-12 with or without interleukin-2 in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are assigned to 1 of 2 treatment cohorts.
COHORT A: Patients receive interleukin-12 (IL-12) IV over 5-15 seconds on days 1, 3, 5, 8, 10, and 12.
COHORT B: Patients receive interleukin-2 (IL-2) IV over 15 minutes twice daily on days 1 and 8 and IL-12 IV as in cohort A.
Treatment in both cohorts repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Some patients may receive additional courses at the discretion of the principal investigator.
Cohorts of 3-6 patients in both cohorts receive escalating doses of IL-2 and IL-12 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.
Once the MTD is determined, an additional cohort of 8 patients receives IL-12 and IL-2 at the MTD.
Patients are followed at 3 weeks.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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California
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Los Angeles, California, États-Unis, 90027
- Children's Hospital Los Angeles
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Los Angeles, California, États-Unis, 90027-6016
- New Approaches to Neuroblastoma Treatment (NANT)
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Palo Alto, California, États-Unis, 94304
- Lucile Packard Children's Hospital Stanford University
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San Francisco, California, États-Unis, 94143-0875
- University of California at San Francisco - Comprehensive Cancer Center
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Georgia
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Atlanta, Georgia, États-Unis, 30322
- AFLAC Cancer Center and Blood Disorders Service
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Illinois
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Chicago, Illinois, États-Unis, 60614
- Childrens Memorial Hospital
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Indiana
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Indianapolis, Indiana, États-Unis, 46202
- Riley Hospital for Children
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Massachusetts
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Boston, Massachusetts, États-Unis, 02115
- Children's Hospital Boston
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- University of Michigan University Hospital
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Ohio
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Cincinnati, Ohio, États-Unis, 45229
- Cincinnati Children's Hospital Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- Children's Hospital of Philadelphia
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Texas
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Houston, Texas, États-Unis, 77030
- Texas Children's Hospital
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Washington
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Seattle, Washington, États-Unis, 98105
- Seattle Children's Hospital
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Wisconsin
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Madison, Wisconsin, États-Unis, 53792
- University of Wisconsin Hospital and Clinics
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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:
Diagnosis of neuroblastoma
- Histologically confirmed disease AND/OR disease defined by tumor cells in the bone marrow and elevated urinary catecholamine metabolites
Persistent and/or refractory disease, with at least 1 of the following:
- Biopsy-proven residual disease at least 12 weeks after myeloablative therapy
- Progressive disease after nonmyeloablative or myeloablative therapy
Recurrent disease, evidenced by any of the following:
- Biopsy-proven recurrent soft tissue disease
- Metaiodobenzylguanidine (MIBG)-positive lesions visible on any other imaging modality or repeat MIBG obtained 2-4 weeks or more apart
- Histologically confirmed bone marrow disease
- Progressive or stable disease after at least 1 prior standard salvage regime
- No clinically significant pleural effusion
- ECOG 0-1
- Life expectancy >= 12 weeks
- Hepatitis A antibody negative
Hepatitis B surface antigen negative
- Positive hepatitis B titer allowed if patient has been immunized and has no history of disease
- Hepatitis C virus negative
- No history of congenital or acquired coagulation disorder
- Cardiac function normal by ECG
- No dyspnea at rest
- No exercise intolerance
- Oxygen saturation at least 94% by pulse oximetry
- DLCO greater than 60% of predicted
- FEV1 greater than 70% of predicted
- Negative pregnancy test
- Skull-based bony lesions without space-occupying intracranial extension are allowed
- No prior or concurrent intracranial metastatic disease to the brain parenchyma
- Not pregnant or nursing
- Fertile patients must use effective barrier contraception during and for at least 2 months after study
- No prior hematologic malignancy (including leukemia or lymphoma)
- No history of malignant hyperthermia
- No prior or concurrent autoimmune disease
- No positive direct Coombs testing
- No history of ongoing or intermittent bowel obstruction
- No active infection or other significant systemic illness
- More than 2 weeks since prior fenretinide
- More than 2 weeks since prior 13-cis-retinoic acid
- More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
- More than 2 weeks since prior interferons or interleukins
- More than 2 weeks since prior cytokine-fusion proteins
- More than 2 weeks since prior IV immunoglobulin (IVIG)
- No prior interleukin-12
- No concurrent cytokines
- No concurrent fenretinide
- No concurrent 13-cis-retinoic acid
No other concurrent immunomodulators, including:
- G-CSF and GM-CSF
- Interferons
- Other interleukins
- IVIG
- More than 4 weeks since prior chemotherapy
- No other unstable medical condition or critical illness that would preclude study participation
- More than 12 weeks since prior myeloablative chemotherapy followed by autologous stem cell transplantation:
No prior myeloablative chemotherapy followed by allogeneic bone marrow transplantation
- More than 2 weeks since prior growth hormones
- More than 4 weeks since prior systemic corticosteroids
- More than 2 weeks since prior non-corticosteroid hormonal therapy (including oral birth control pills)
- No concurrent hormonal therapy (including oral birth control pills)
- No concurrent growth hormones
- No concurrent systemic corticosteroids, except for use in life-threatening complications
- More than 4 weeks since prior radiotherapy
- No prior solid organ transplantation
- More than 4 weeks since prior investigational agents
- No other concurrent investigational agents
- No prior enrollment on COG-A3973, unless disease has progressed
- No history of hemolytic anemia
- Absolute neutrophil count at least 1,500/mm^3 [Note: Independent of growth factor or transfusion support]
- Platelet count at least 75,000/mm^3 [Note: Independent of growth factor or transfusion support]
- AST and ALT less than 2.5 times upper limit of normal
- Bilirubin less than 2.0 mg/dL
- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min OR creatinine normal
- HIV negative
- Ejection fraction at least 50% by echocardiogram or MUGA OR Fractional shortening at least 30% by echocardiogram
- No congestive heart failure
- No uncontrolled cardiac arrhythmia
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: Treatment (IL-12, aldesleukin)
Cohort A: Patients receive interleukin-12 (IL-12) IV over 5-15 seconds on days 1, 3, 5, 8, 10, and 12. Cohort B: Patients receive interleukin-2 (IL-2) IV over 15 minutes twice daily on days 1 and 8 and IL-12 IV as in cohort A. Treatment in both cohorts repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Some patients may receive additional courses at the discretion of the principal investigator. Cohorts of 3-6 patients in both cohorts receive escalating doses of IL-2 and IL-12 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. Once the MTD is determined, an additional cohort of 8 patients receives IL-12 and IL-2 at the MTD. |
Étant donné IV
Autres noms:
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 (MTD) assessed by Common Toxicity Criteria (CTC)
Délai: 28 days
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28 days
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Overall response assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
Délai: Up to 3 weeks
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Up to 3 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jon Wigginton, New Approaches to Neuroblastoma Treatment (NANT)
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 par type histologique
- Tumeurs
- Tumeurs, glandulaires et épithéliales
- Tumeurs, neuroépithéliales
- Tumeurs neuroectodermiques
- Tumeurs, cellules germinales et embryonnaires
- Tumeurs, tissu nerveux
- Tumeurs neuroectodermiques primitives
- Tumeurs neuroectodermiques, primitives, périphériques
- Neuroblastome
- Effets physiologiques des médicaments
- Agents anti-infectieux
- Agents du système nerveux périphérique
- Agents antiviraux
- Agents anti-VIH
- Agents antirétroviraux
- Analgésiques
- Agents du système sensoriel
- Analgésiques, non narcotiques
- Agents antinéoplasiques
- Facteurs immunologiques
- Inhibiteurs de l'angiogenèse
- Agents modulateurs de l'angiogenèse
- Substances de croissance
- Inhibiteurs de croissance
- Adjuvants, immunologique
- Aldesleukine
- Interleukine-12
- Interleukine-2
Autres numéros d'identification d'étude
- NCI-2009-00024
- P01CA081403 (Subvention/contrat des NIH des États-Unis)
- NANT 2001-01
- CDR0000270447 (Identificateur de registre: PDQ (Physician Data Query))
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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