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

Description

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.

Study Start Date

March 2015

Estimated Completion Date

April 2020

Interventions

  • Drug: Vincristine
  • Drug: Carboplatin

Specialties

  • Pediatrics: Pediatric Heme/Oncology,Pediatric Neurology
  • Neurology: Neurologic Oncology,Peds Neurology
  • Oncology: Neurologic Oncology
  • Physician Assistant: Hematology/Oncology,Neurology,Pediatrics

MeSH Terms

  • Glioma
  • Low Grade Glioma
  • Neoplasms
  • Neoplasms
  • Neoplasms, Nerve Tissue
  • Vincristine

Study ID

Ann & Robert H Lurie Children's Hospital of Chicago -- LGG 14C03

Status

Recruiting

Trial ID

NCT02455245

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

160

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Gender

Both

Ages

21 Years and younger

Accepts Healthy Volunteers

No

Study Locations and Contact Information (10)

Study Location Distance Name Phone Email
Yale University - New Haven, Connecticut 18.1 miles Asher M Marks MD None None
DanaFarber Cancer Institute - Boston, Massachusetts 135.8 miles Mark W Kieran MD None None
The Johns Hopkins Hospital - Baltimore, Maryland 219.6 miles Ken Cohen MD None None
Nationwide Childrens Hospital - Columbus, Ohio 518.1 miles Diana S Osorio MD None None
St Vincent Peyton Manning Childrens Hospital - Indianapolis, Indiana 686.2 miles Jessica Goodman MD None None
Ann Robert H Lurie Childrens Hosptial of Chicago - Chicago, Illinois 745.5 miles Carrie Kempler MPH 312-227-4860 ckempler@luriechildrens.org
American Family Childrens Hospital - Madison, Wisconsin 839.6 miles Neha Patel MD 608-263-6200 None
Childrens Hospitals and Clinics of Minnesota Minneapolis - Minneapolis, Minnesota 1,042.1 miles Anne E Bendel MD None None
Phoenix Childrens Hospital - Phoeniz, Arizona 2,181.7 miles Amy Rosenfield MD None None
Rady Childrens Hospital - San Diego, California 2,469.3 miles John Crawford MD None None

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