drugset / Trial / NCT02455245
A Study Comparing Two Carboplatin Containing Regimens for Children and Young Adults With Previously Untreated Low Grade Glioma
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is trying to learn and understand if the chemotherapy drug called carboplatin works as well as the standard therapy. The standard therapy for Low Grade Glioma (LGG) in children and young adults is using a combination of carboplatin and vincristine. Studies in children have shown that the use of carboplatin alone has promise of being just as effective for treating LGG as standard therapy. Additionally, this study will try to understand if treatment with carboplatin alone is associated with an improved quality of life for LGG patients and their families.
Timeline
- Start
- 2015-03
- Primary completion
- 2025-08-31
- Completion
- 2025-11-30
Publications
- Background Sievert AJ, Fisher MJ. Pediatric low-grade gliomas. J Child Neurol. 2009 Nov;24(11):1397-408. doi: 10.1177/0883073809342005.
- Background Gururangan S, Cavazos CM, Ashley D, Herndon JE 2nd, Bruggers CS, Moghrabi A, Scarcella DL, Watral M, Tourt-Uhlig S, Reardon D, Friedman HS. Phase II study of carboplatin in children with progressive low-grade gliomas. J Clin Oncol. 2002 Jul 1;20(13):2951-8. doi: 10.1200/JCO.2002.12.008.
- Background Sharif S, Ferner R, Birch JM, Gillespie JE, Gattamaneni HR, Baser ME, Evans DG. Second primary tumors in neurofibromatosis 1 patients treated for optic glioma: substantial risks after radiotherapy. J Clin Oncol. 2006 Jun 1;24(16):2570-5. doi: 10.1200/JCO.2005.03.8349.
- Background Petronio J, Edwards MS, Prados M, Freyberger S, Rabbitt J, Silver P, Levin VA. Management of chiasmal and hypothalamic gliomas of infancy and childhood with chemotherapy. J Neurosurg. 1991 May;74(5):701-8. doi: 10.3171/jns.1991.74.5.0701.
- Background Packer RJ, Lange B, Ater J, Nicholson HS, Allen J, Walker R, Prados M, Jakacki R, Reaman G, Needles MN, et al. Carboplatin and vincristine for recurrent and newly diagnosed low-grade gliomas of childhood. J Clin Oncol. 1993 May;11(5):850-6. doi: 10.1200/JCO.1993.11.5.850.
- Background Lafay-Cousin L, Sung L, Carret AS, Hukin J, Wilson B, Johnston DL, Zelcer S, Silva M, Odame I, Mpofu C, Strother D, Bouffet E. Carboplatin hypersensitivity reaction in pediatric patients with low-grade glioma: a Canadian Pediatric Brain Tumor Consortium experience. Cancer. 2008 Feb 15;112(4):892-9. doi: 10.1002/cncr.23249.
- Background Korinthenberg R, Neuburger D, Nikkhah G, Teske C, Schnabel K, Calaminus G. Assessing quality of life in long-term survivors after (1)(2)(5)I brachytherapy for low-grade glioma in childhood. Neuropediatrics. 2011 Jun;42(3):110-5. doi: 10.1055/s-0031-1283111. Epub 2011 Jul 7.
- Background Bryant R. Managing side effects of childhood cancer treatment. J Pediatr Nurs. 2003 Apr;18(2):113-25. doi: 10.1053/jpdn.2003.11.
- Background Woodgate RL, Degner LF, Yanofsky R. A different perspective to approaching cancer symptoms in children. J Pain Symptom Manage. 2003 Sep;26(3):800-17. doi: 10.1016/s0885-3924(03)00285-9.
- Background Kazak AE, Simms S, Rourke MT. Family systems practice in pediatric psychology. J Pediatr Psychol. 2002 Mar;27(2):133-43. doi: 10.1093/jpepsy/27.2.133.
- Background Mulhern RK, Carpentieri S, Shema S, Stone P, Fairclough D. Factors associated with social and behavioral problems among children recently diagnosed with brain tumor. J Pediatr Psychol. 1993 Jun;18(3):339-50. doi: 10.1093/jpepsy/18.3.339.
- Background Katz ER, Varni JW. Social support and social cognitive problem-solving in children with newly diagnosed cancer. Cancer. 1993 May 15;71(10 Suppl):3314-9. doi: 10.1002/1097-0142(19930515)71:10+3.0.co;2-1.
- Background O'Malley JE, Koocher G, Foster D, Slavin L. Psychiatric sequelae of surviving childhood cancer. Am J Orthopsychiatry. 1979 Oct;49(4):608-616. doi: 10.1111/j.1939-0025.1979.tb02646.x.
- Background Vannatta K, Gartstein MA, Short A, Noll RB. A controlled study of peer relationships of children surviving brain tumors: teacher, peer, and self ratings. J Pediatr Psychol. 1998 Oct;23(5):279-87. doi: 10.1093/jpepsy/23.5.279.
- Background Lavigne JV, Faier-Routman J. Psychological adjustment to pediatric physical disorders: a meta-analytic review. J Pediatr Psychol. 1992 Apr;17(2):133-57. doi: 10.1093/jpepsy/17.2.133.
- Background Patenaude AF, Kupst MJ. Psychosocial functioning in pediatric cancer. J Pediatr Psychol. 2005 Jan-Feb;30(1):9-27. doi: 10.1093/jpepsy/jsi012.
- Background Dolgin MJ, Somer E, Buchvald E, Zaizov R. Quality of life in adult survivors of childhood cancer. Soc Work Health Care. 1999;28(4):31-43. doi: 10.1300/J010v28n04_03.
- Background Oeffinger KC, Robison LL. Childhood cancer survivors, late effects, and a new model for understanding survivorship. JAMA. 2007 Jun 27;297(24):2762-4. doi: 10.1001/jama.297.24.2762. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 19 mg/kg | Intravenous |
| Subject | Carboplatin | Small molecule | 175 mg/m2 | Intravenous |
| Subject | Carboplatin | Small molecule | 560 mg/m2 | Intravenous |
| Subject | Vincristine | Small molecule | 0.05 mg/kg | Intravenous |
| Subject | Vincristine | Small molecule | 1.5 mg/m2 | Intravenous |