Low Grade GliomaPhase 3NCT02455245
A Study Comparing Two Carboplatin Containing Regimens for Children and Young Adults With Previously Untreated Low Grade Glioma
A Phase 3 study testing Carboplatin and Vincristine and Carboplatin in people with Low Grade Glioma, run by Alicia Lenzen at 21 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Low Grade Glioma
- What is being tested?
- Carboplatin and Vincristine and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 21 sitesUnited States
- Study dates
- Mar 2015to 30 Nov 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Tumor Diagnosis: Low grade gliomas
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- Patients who are receiving any other investigational or chemotherapeutic agents will be excluded.
- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308-1062
Albany Medical Center
Albany, New York, 12208-3479
University of Michigan, C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109-5652
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Ann & Robert H. Lurie Children's Hosptial of Chicago
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
Dayton Children's Hospital
Dayton, Ohio, 45404-1815
Duke University Medical School
Durham, North Carolina, 27705-4682
St. Vincent Peyton Manning Children's Hospital
Indianapolis, Indiana, 46260
University of Iowa
Iowa City, Iowa, 52242
American Family Children's Hospital
Madison, Wisconsin, 53792
Medical College of Wiscosin
Milwaukee, Wisconsin, 53226
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
Yale University
New Haven, Connecticut, 06520
Orlando Health, Inc.
Orlando, Florida, 32806
Phoenix Children's Hospital
Phoeniz, Arizona, 85016
Rady Children's Hospital
San Diego, California, 92123
Saint Louis University at SSM Cardinal Glennon Children's Medical Center
St Louis, Missouri, 63103-2006
Washington University School of Medicine
St Louis, Missouri, 63110-1010
About this study
Official title: A Phase III Study Comparing Two Carboplatin Containing Regimens for Children and Young Adults With Previously Untreated Low Grade Glioma
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.
Read the detailed description
Low grade gliomas are the most common central nervous system (CNS) tumors in the pediatric population. They consist of a heterogeneous group of tumors that are classified as World Health Organization (WHO) grade I or II. This includes astrocytic, oligodendroglial, neuronal and mixed glial- neuronal tumors. The clinical behavior of these tumors varies according to location and histology. The cerebellum is the most common location for low grade gliomas, but they can also arise in the cerebrum, deep midline structures such as the hypothalamus, optic pathway and, less frequently, in the brainstem.
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
- Low Grade Glioma
- Being tested
- Carboplatin and Vincristine, Carboplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carboplatin and VincristineDrug
Carboplatin 175 mg/m2 IV infusion Vincristine 1.5mg/m2 IV
CarboplatinDrug
Carboplatin 560 mg/m2 (or 19 mg/kg for children weighing less than 12 kg) IV
| Study group | Role | What they receive |
|---|---|---|
| Carboplatine and Vincristine | Active comparator | 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. Receives: Drug: Carboplatin and Vincristine; Drug: Carboplatin |
| Carboplatin alone | Experimental | 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 Receives: Drug: Carboplatin and Vincristine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
To compare the progression-free survival (PFS) in patients with previously untreated LGG among patients with and without NF1 utilizing carboplatin/vincristine (standard of care) vs single agent carboplatin (research).
Measured: 3 years
Secondary outcomes (5)
Number of participants who experience improved quality of life as assessed by a Quality of Life questionnaire.
To compare the QOL among both regimens.
Measured: week-6, week-12, month-6, month-12
Tumor response rate of each regimen, assessed by magnetic resonance imaging (MRI)
To estimate tumor response rates of each regimen.
Measured: 3 years
Number of participants who experience toxicity on each regimen
To determine toxicity of each regimen
Measured: 3 years
Number of B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutations that have an association with clinical outcomes.
To assess the molecular findings and correlate with clinical outcome.
Measured: 3 years
Number of aberrations found through whole exome and ribonucleic acid (RNA) sequencing that coordinate with a clinical outcome.
To assess the molecular findings and correlate with clinical outcome.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startMar 2015
- Primary completion31 Aug 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Low Grade GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alicia Lenzen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alicia Lenzen, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Alicia Lenzen, MD, Principal investigator, Attending
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455245
- Sponsor's protocol ID
- LGG 14C03
- Status last verified
- Aug 2026
- First submitted
- 13 Apr 2015
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Sievert AJ, Fisher MJ. Pediatric low-grade gliomas. J Child Neurol. 2009 Nov;24(11):1397-408. doi: 10.1177/0883073809342005.
PubMed 19841428Gururangan 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.
PubMed 12089224Sharif 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.
PubMed 16735710Petronio 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.
PubMed 1901597Packer 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.
PubMed 8487049Lafay-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.
PubMed 18098210Korinthenberg 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.
PubMed 21739406Bryant R. Managing side effects of childhood cancer treatment. J Pediatr Nurs. 2003 Apr;18(2):113-25. doi: 10.1053/jpdn.2003.11.
PubMed 12720208Woodgate 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.
PubMed 12967729Kazak 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.
PubMed 11821497Mulhern 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.
PubMed 8340843Katz 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.
PubMed 8490874O'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.
PubMed 495703Vannatta 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.
PubMed 9782676Lavigne 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.
PubMed 1534367
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study Comparing Two Carboplatin Containing Regimens for Children and Young Adults With Previously Untreated Low Grade Glioma
- ClinicalTrials.gov ID
- NCT02455245
- Acronym / sponsor ID
- LGG 14C03
- Conditions
- Low Grade Glioma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Alicia LenzenUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Low grade gliomas are the most common central nervous system (CNS) tumors in the pediatric population. They consist of a heterogeneous group of tumors that are classified as World Health Organization (WHO) grade I or II. This includes astrocytic, oligodendroglial, neuronal and mixed glial- neuronal tumors. The clinical behavior of these tumors varies according to location and histology. The cerebellum is the most common location for low grade gliomas, but they can also arise in the cerebrum, deep midline structures such as the hypothalamus, optic pathway and, less frequently, in the brainstem.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carboplatine and Vincristine | Active comparator | Drug: Carboplatin and Vincristine, Drug: CarboplatinInduction: 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 alone | Experimental | Drug: Carboplatin and VincristineCarboplatin 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 |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Tumor Diagnosis: Low grade gliomas
- 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
Key exclusion criteria (6 listed)
- Patients who are receiving any other investigational or chemotherapeutic agents will be excluded.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carboplatin and VincristineCarboplatin 175 mg/m2 IV infusion Vincristine 1.5mg/m2 IV | Drug | Carboplatin alone, Carboplatine and Vincristine |
| CarboplatinCarboplatin 560 mg/m2 (or 19 mg/kg for children weighing less than 12 kg) IV | Drug | Carboplatine and Vincristine |
Primary outcome
Progression-free survival
Time frame: 3 years
To compare the progression-free survival (PFS) in patients with previously untreated LGG among patients with and without NF1 utilizing carboplatin/vincristine (standard of care) vs single agent carboplatin (research).
5 secondary outcomes
Number of participants who experience improved quality of life as assessed by a Quality of Life questionnaire.
Time frame: week-6, week-12, month-6, month-12
Tumor response rate of each regimen, assessed by magnetic resonance imaging (MRI)
Time frame: 3 years
Number of participants who experience toxicity on each regimen
Time frame: 3 years
Number of B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutations that have an association with clinical outcomes.
Time frame: 3 years
Number of aberrations found through whole exome and ribonucleic acid (RNA) sequencing that coordinate with a clinical outcome.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 19841428Sievert AJ, Fisher MJ. Pediatric low-grade gliomas. J Child Neurol. 2009 Nov;24(11):1397-408. doi: 10.1177/0883073809342005.
- Background: PubMed 12089224Gururangan 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: PubMed 16735710Sharif 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: PubMed 1901597Petronio 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: PubMed 8487049Packer 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: PubMed 18098210Lafay-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: PubMed 21739406Korinthenberg 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: PubMed 12720208Bryant R. Managing side effects of childhood cancer treatment. J Pediatr Nurs. 2003 Apr;18(2):113-25. doi: 10.1053/jpdn.2003.11.
- Background: PubMed 12967729Woodgate 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: PubMed 11821497Kazak 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: PubMed 8340843Mulhern 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: PubMed 8490874Katz 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.
Related trials for Low Grade Glioma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 2
Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas
BRAF V600 Mutation, Low-grade Glioma
Active, not recruitingPhase 2
Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype
Glioma, Glioblastoma
Active, not recruitingPhase 3
DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
Low-grade Glioma, Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma
RecruitingPhase 1/2
Phase 1/2 Study of Mirdametinib + Vinblastine for Newly Diagnosed/Previously Untreated PLGG + Activation of MAPK
Pediatric Low-grade Glioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicia Lenzen, MD principal investigator
Attending
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Carboplatin and Vincristine and Carboplatin in people with Low Grade Glioma, run by Alicia Lenzen at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02455245, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.