A Study Comparing Two Carboplatin Containing Regimens for Children and Young Adults With Previously Untreated Low Grade Glioma
NCT ID: NCT02455245
Last Updated: 2024-11-26
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
95 participants
INTERVENTIONAL
2015-03-31
2025-11-30
Brief Summary
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Detailed Description
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Although the etiology of most childhood LGG is unknown, patients with Neurofibromatosis type 1 (NF-1) are one rare group predisposed to developing CNS tumors. NF-1 is an inherited disorder that affects the nervous system, eyes and skin. In addition, children are at an increased risk for developing optic pathway and hypothalamic low grade gliomas. Fifteen to-20% of NF-1 patients will develop these tumors, and they account for up to 70% of the tumors seen in this location. In half of patients with NF-1 and an optic pathway tumor, the patients are not symptomatic and the mass is found incidentally. Many optic gliomas in NF-1 patients follow an indolent course and stabilize without intervention. Patients are most commonly treated when there is deterioration in their vision or a symptomatic increase in the tumor size. Although the event free survival (EFS) has been reported to be similar between NF1 and non-NF1 patients, overall survival is higher in NF1 patients.
Location, as it affects the extent of surgical resection, plays a key role in the prognosis of all patients with low grade gliomas. Complete surgical resection offers a 90% survival rate at 10 years with often no need for adjuvant chemotherapy or radiation. Unfortunately, a gross total resection is not always possible due to the location of the tumor and its proximity to vital structures in the brain. In patients with an incomplete resection, the 10 year EFS is up to 74% with radiation treatment. However, toxicity from radiation, especially in young children, is significant and includes neurocognitive delays, endocrinopathies, secondary malignancy, ototoxicity and vasculopathy. Therefore, most experts agree that the standard of care in young children is to treat low grade gliomas that require adjuvant therapy after surgical resection/biopsy, or whose tumors are not surgically resectable with chemotherapy first, in order to delay or avoid radiation. This is especially true in children with NF-1, where the risk of a secondary malignancy after radiation therapy can be as high as 50% in the lifetime of the child.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Carboplatine and Vincristine
Induction: 10 weeks of Carboplatin and Vincristine therapy. Carboplatin 175 mg/m2 give an an IV infusion weeks 1, 2, 3, 4, 7, 8, 9, 10. Vincristine 1.5mg/m2 (0.05 mg/kg if child less than 12 kg) (maximum dose 2.0 mg) give as an IV bolus infusion on weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10.
Maintenance: Maintenance consists of 8, 6-week cycles of chemotherapy. It begins week 12 of Induction or when peripheral counts recover with ANC \>1,000/µL and platelet count \>100,000/µL. Each cycle will consist of 4 weekly doses of carboplatin, three weekly doses of vincristine (given concomitantly with the first 3 weeks of carboplatin), followed by two weeks of rest for a total of 6 weeks. Maintenance will continue for a total of 8 cycles.
Carboplatin 175 mg/m2 as an IV continuous infusion over 60 minutes on Week 1, 2, 3, 4 of each cycle. Vincristine 1.5 mg/m2 (0.05 mg/ kg for children \<12 kg) (maximum dose 2.0 mg) IV bolus infusion on Week 1, 2, 3 of each cycle.
Carboplatin and Vincristine
Carboplatin 175 mg/m2 IV infusion Vincristine 1.5mg/m2 IV
Carboplatin
Carboplatin 560 mg/m2 (or 19 mg/kg for children weighing less than 12 kg) IV
Carboplatin alone
Carboplatin is given once every four weeks, Each 4-week period is considered a cycle. Regimen B will last for 13 cycles which is equivalent to one year (52 weeks).
Carboplatin 560 mg/m2 (or 19 mg/kg for children weighing less than 12 kg) IV over 1 hour every 4 weeks
Carboplatin and Vincristine
Carboplatin 175 mg/m2 IV infusion Vincristine 1.5mg/m2 IV
Interventions
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Carboplatin and Vincristine
Carboplatin 175 mg/m2 IV infusion Vincristine 1.5mg/m2 IV
Carboplatin
Carboplatin 560 mg/m2 (or 19 mg/kg for children weighing less than 12 kg) IV
Eligibility Criteria
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Inclusion Criteria
* Patients must be less than 21 years of age at study entry.
* Central nervous system tumor. Patients with primary spinal cord lesions. Patients with metastatic disease are also allowed.
* No previous therapy for the tumor with the exception of corticosteroids and surgery.
* Performance status:Karnofsky Performance Scale (KPS for \> 16 yrs of age) or Lansky Performance Score (LPS for ≤ 16 years of age) ≥ 50 assessed within two weeks prior to registration
* Seizure disorder should be well controlled.
* Normal organ and marrow function
* Female patients of childbearing potential must not be pregnant or breast-feeding. Female patients who have menstruated and are of childbearing potential must have a negative serum or urine pregnancy test prior to enrollment.
* Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study and for 6 months after the last drug administration.
* Ability of subject or parent/guardian to understand and the willingness to sign a written informed consent/assent document. Informed consent/assent must be signed prior to registration on this study.
* Tissue blocks or slides must be sent. If tissue is unavailable, the study chair must be notified prior to enrollment.
Exclusion Criteria
* Patients with known inability to return for follow-up visits or obtain follow-up studies required to assess for toxicity to therapy.
* Patients with Subepenydmal Giant Cell Astrocytomas are excluded. Patients with intrinsic brainstem tumors of the pons will be excluded from the study.
* History of hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to platinum based chemotherapy.
* Patients with uncontrolled inter-current illness are excluded.
* Females who are pregnant or breast feeding are excluded.
21 Years
ALL
No
Sponsors
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Alicia Lenzen
OTHER
Responsible Party
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Alicia Lenzen
Attending
Principal Investigators
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Alicia Lenzen, MD
Role: PRINCIPAL_INVESTIGATOR
Attending
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Rady Children's Hospital
San Diego, California, United States
Yale University
New Haven, Connecticut, United States
Orlando Health, Inc.
Orlando, Florida, United States
Ann & Robert H. Lurie Children's Hosptial of Chicago
Chicago, Illinois, United States
St. Vincent Peyton Manning Children's Hospital
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan, C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States
Saint Louis University at SSM Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Albany Medical Center
Albany, New York, United States
Duke University Medical School
Durham, North Carolina, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Dayton Children's Hospital
Dayton, Ohio, United States
American Family Children's Hospital
Madison, Wisconsin, United States
Medical College of Wiscosin
Milwaukee, Wisconsin, United States
Countries
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References
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Bryant R. Managing side effects of childhood cancer treatment. J Pediatr Nurs. 2003 Apr;18(2):113-25. doi: 10.1053/jpdn.2003.11.
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.
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.
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.
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.
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.
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.
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.
Patenaude AF, Kupst MJ. Psychosocial functioning in pediatric cancer. J Pediatr Psychol. 2005 Jan-Feb;30(1):9-27. doi: 10.1093/jpepsy/jsi012.
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.
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.
Sievert AJ, Fisher MJ. Pediatric low-grade gliomas. J Child Neurol. 2009 Nov;24(11):1397-408. doi: 10.1177/0883073809342005.
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.
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.
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.
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.
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.
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.
Other Identifiers
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LGG 14C03
Identifier Type: -
Identifier Source: org_study_id
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