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

• Status: Unknown status
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Natasha Pillay Smiley
• Treatments: Carboplatin; Vincristine

Criteria

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.