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- Essai clinique NCT01858571
Low Dose Chemotherapy Versus Best Supportive Care in Progressive Pediatric Malignancies
Low Dose Chemotherapy (Metronomic Therapy) Versus Best Supportive Care in Progressive and/or Refractory Pediatric Malignancies: a Double Blind Placebo Controlled Randomized Study
Many of the pediatric malignancies are not curable on progression on front line or 2nd line chemotherapy. Further therapy with conventional drugs imposes many side effects and decreases the QOL. The usual therapy offered to such patients is best supportive care.
Metronomic chemotherapy can induce tumor stabilization or tumor responses in patients with cancer that are refractory or have relapsed after conventional chemotherapy. Whether metronomic therapy is better than best supportive care is not known. In order to do so, a study is required which may compare metronomic therapy with a placebo therapy on PFS and QOL in relapsed refractory cases of pediatric solid tumors who have failed at least two lines of chemotherapy.
HYPOTHESIS
The investigators hypothesize that metronomic chemotherapy in progressive pediatric malignancy will improve PFS and QOL. If validated, then this form for therapy will be an option for both the patients and the clinicians, who are left with just an option of best supportive care in such situations of progressive pediatric cancers despite multiple lines of chemotherapy.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Many of the pediatric malignancies are not curable on progression on front line or 2nd line chemotherapy. Further therapy with conventional drugs imposes many side effects and decreases the QOL. The usual therapy offered to such patients is best supportive care.
Metronomic chemotherapy can induce tumor stabilization or tumor responses in patients with cancer that are refractory or have relapsed after conventional chemotherapy. Whether metronomic therapy is better than best supportive care is not known. In order to do so, a study is required which may compare metronomic therapy with a placebo therapy on PFS and QOL in relapsed refractory cases of pediatric solid tumors who have failed at least two lines of chemotherapy.
It will be double blind randomized study. One group will receive metronomic therapy along with best supportive care and other will receive placebo and best supportive care.
The treatment will be continued till progression is documented. Metronomic chemotherapy schedule : Alternating cycles of Cycle A and B (Each cycle includes 3 weeks of drug administration) with each drug rounded off to the nearest tablet/capsule size.
Cycle A
- Daily oral Thalidomide (at 3mg/kg)
- Daily oral Celecoxib (100 mg BID for patients < 20 kg, 200 mg BID for patients 20-50 kg, and 400 mg BID for patients > 50 kg)
- Daily oral Etoposide (50 mg/m2/d) Cycle B
- Daily oral Thalidomide (at 3mg/kg)
- Daily oral Celecoxib (100 mg BID for patients < 20 kg, 200 mg BID for patients 20-50 kg, and 400 mg BID for patients > 50 kg)
- Daily oral Cyclophosphamide (2.5 mg/kg/d to a maximum of 100 mg/d) every 21 days
Placebo: Alternating cycles of Cycle A and B (Each cycle includes 3 weeks of drug administration)
- Capsules of same size and color as used in metronomic therapy Best supportive care
- Management of pain as per WHO standard for pain management
The dose of medications in capsules have to be rounded off to the nearest capsule size. Instead of rounding off on the daily dose, the total dose over the week would be calculated and rounded off and divided over 5-6 days in a week. This is being done so as to prevent any extra dosing.
If any grade 3-4 toxicity occurs in the first course, then the dose for chemotherapy would be reduced in the subsequent course by 20%.
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
-
-
Delhi
-
New Delhi, Delhi, Inde, 110029
- All India Institute of Medical Sciences
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Refractory/Progressive non hematopoietic extracranial solid tumors following treatment with at least 2 lines of chemotherapy.
- ECOG performance status (<=3)(at least patients ambulating with crutches or on wheel chair)
- Age: 5-18 years
- Recovered from all acute toxic effects of earlier therapy
- Absolute neutrophil count > 1X 109/L
- Absolute platelet count > 75 x 109/L
- Normal renal functions
- Serum bilirubin <1.5 times the upper limit of normal, and the serum aspartate aminotransferase and alanine aminotransferase < 5 times the upper limit of normal.
Exclusion Criteria:
- Uncontrolled concurrent illness or active infection
- Positive serology for human immunodeficiency.
- Unable to swallow oral medication
- Pregnant and breast-feeding
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Low dose chemotherapy
Alternating cycles of Cycle A and B (Each cycle includes 3 weeks of drug administration) with each drug rounded off to the nearest tablet/capsule size. Cycle A
Cycle B
|
Metronomic chemotherapy schedule : Alternating cycles of Cycle A and B (Each cycle includes 3 weeks of drug administration) with each drug rounded off to the nearest tablet/capsule size. Cycle A
Cycle B
Autres noms:
|
Comparateur placebo: Best supportive care
Placebo: Alternating cycles of Cycle A and B (Each cycle includes 3 weeks of drug administration)
|
Metronomic chemotherapy schedule : Alternating cycles of Cycle A and B (Each cycle includes 3 weeks of drug administration) with each drug rounded off to the nearest tablet/capsule size. Cycle A
Cycle B
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Survie sans progression
Délai: Jusqu'à 2 ans
|
Jusqu'à 2 ans
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
La survie globale
Délai: Jusqu'à 2 ans
|
Jusqu'à 2 ans
|
Autres mesures de résultats
Mesure des résultats |
Délai |
---|---|
Quality of life
Délai: Up to 2 years
|
Up to 2 years
|
Bio marker of angiogenesis (VEGF)
Délai: Up to 2 years
|
Up to 2 years
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Sameer Bakhshi, MD, All India Institute of Medical Sciences, New Delhi
Publications et liens utiles
Publications générales
- Pramanik R, Agarwala S, Sreenivas V, Dhawan D, Bakhshi S. Quality of life in paediatric solid tumours: a randomised study of metronomic chemotherapy versus placebo. BMJ Support Palliat Care. 2021 Jan 19:bmjspcare-2020-002731. doi: 10.1136/bmjspcare-2020-002731. Online ahead of print.
- Pramanik R, Agarwala S, Gupta YK, Thulkar S, Vishnubhatla S, Batra A, Dhawan D, Bakhshi S. Metronomic Chemotherapy vs Best Supportive Care in Progressive Pediatric Solid Malignant Tumors: A Randomized Clinical Trial. JAMA Oncol. 2017 Sep 1;3(9):1222-1227. doi: 10.1001/jamaoncol.2017.0324.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
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
Termes MeSH pertinents supplémentaires
- Tumeurs
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-infectieux
- Agents du système nerveux périphérique
- Inhibiteurs d'enzymes
- Analgésiques
- Agents du système sensoriel
- Agents anti-inflammatoires non stéroïdiens
- Analgésiques, non narcotiques
- Agents anti-inflammatoires
- Agents antirhumatismaux
- Inhibiteurs de la cyclooxygénase
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Agents antinéoplasiques, alkylants
- Agents d'alkylation
- Agonistes myéloablatifs
- Agents antinéoplasiques phytogéniques
- Inhibiteurs de la topoisomérase II
- Inhibiteurs de la topoisomérase
- Inhibiteurs de l'angiogenèse
- Agents modulateurs de l'angiogenèse
- Substances de croissance
- Inhibiteurs de croissance
- Agents antibactériens
- Agents léprostatiques
- Inhibiteurs de la cyclooxygénase 2
- Cyclophosphamide
- Étoposide
- Thalidomide
- Célécoxib
Autres numéros d'identification d'étude
- IEC/NP-63/2013
Informations sur les médicaments et les dispositifs, documents d'étude
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