A Study Comparing Two Carboplatin Containing Regimens for Children and Young Adults With Previously Untreated Low Grade Glioma

NCT02455245 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: LGG 14C03
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 21

Brief 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.

Conditions

Low Grade Glioma

Outcome Measures

Primary Outcomes (1)

• 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).

  3 years

Secondary Outcomes (5)

• Number of participants who experience improved quality of life as assessed by a Quality of Life questionnaire.

  week-6, week-12, month-6, month-12

• Tumor response rate of each regimen, assessed by magnetic resonance imaging (MRI)

  3 years

• Number of participants who experience toxicity on each regimen

  3 years

• Number of B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutations that have an association with clinical outcomes.

  3 years

• Number of aberrations found through whole exome and ribonucleic acid (RNA) sequencing that coordinate with a clinical outcome.

  3 years

Study Arms (2)

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.

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

Drug: Carboplatin and Vincristine

Interventions

Carboplatin and Vincristine DRUG

Carboplatin 175 mg/m2 IV infusion Vincristine 1.5mg/m2 IV

Carboplatin alone; Carboplatine and Vincristine

Carboplatin DRUG

Carboplatin 560 mg/m2 (or 19 mg/kg for children weighing less than 12 kg) IV

Carboplatine and Vincristine

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alicia Lenzen: lead

Study Sites (21)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Rady Children's Hospital

San Diego, California, 92123, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Orlando Health, Inc.

Orlando, Florida, 32806, United States

Location

Ann & Robert H. Lurie Children's Hosptial of Chicago

Chicago, Illinois, 60611, United States

Location

St. Vincent Peyton Manning Children's Hospital

Indianapolis, Indiana, 46260, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Michigan, C.S. Mott Children's Hospital

Ann Arbor, Michigan, 48109-5652, United States

Location

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404, United States

Location

Saint Louis University at SSM Cardinal Glennon Children's Medical Center

St Louis, Missouri, 63103-2006, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110-1010, United States

Location

Albany Medical Center

Albany, New York, 12208-3479, United States

Location

Duke University Medical School

Durham, North Carolina, 27705-4682, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308-1062, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Dayton Children's Hospital

Dayton, Ohio, 45404-1815, United States

Location

American Family Children's Hospital

Madison, Wisconsin, 53792, United States

Location

Medical College of Wiscosin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (18)

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• 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.

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• 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.

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MeSH Terms

Interventions

Carboplatin; Vincristine

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Alicia Lenzen, MD

  Attending

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: May 27, 2015
• Study Start: March 1, 2015
• Primary Completion: August 31, 2025
• Study Completion: November 30, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

US (21)