Clinical Trial: Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed, Non-Metastatic Desmoplastic Medulloblastoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II Study for the Treatment of Non-metastatic Nodular Desmoplastic Medulloblastoma in Children Less Than 4 Years of Age
Brief Summary: This phase II trial studies how well combination chemotherapy works in treating younger patients with newly diagnosed, non-metastatic desmoplastic medulloblastoma. Drugs used in chemotherapy, such as vincristine sulfate, cyclophosphamide, methotrexate, etoposide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Detailed Summary:
PRIMARY OBJECTIVES:
I. Estimate of the progression free survival (PFS) distribution for patients 0-<4 years of age with M0 desmoplastic medulloblastoma (nodular desmoplastic or medulloblastoma with extensive nodularity) treated with the modified HIT SKK regimen (excluding the use of intraventricular methotrexate).
SECONDARY OBJECTIVES:
I. Evaluate the feasibility of a rapid central pathology screening review for treatment allocation according to histology and assess agreement between institutional and central pathology review diagnoses as well as among central pathology review diagnoses.
II. Prospectively evaluate the molecular profile of nodular desmoplastic (ND)/medulloblastoma with extensive nodularity (MBEN) medulloblastoma in young children.
III. Monitor and describe the neurocognitive and adaptive functioning of young children with ND/MBEN medulloblastoma treated on this protocol using the ALTE07C1 protocol.
OUTLINE:
INDUCTION THERAPY: Patients receive vincristine sulfate intravenously (IV) over 1 minute or infused via minibag on days 1, 15, and 29; cyclophosphamide IV over 1 hour on days 1-3; methotrexate IV over 24 hours on days 15 and 29; etoposide IV over 60-120 minutes on days 43-45; and carboplatin IV over 1 hour on days 43-45. Treatment repeats every 63 days for 3 courses in the absence of disease progression or unacceptable toxicity.
CONTINUATION THERAPY: Patients receive vincristine sulfate IV over 1 minute or infused via minibag on day 1, cyclophosphamide IV over 1 hour on days 1-3, etoposide IV over 60-120 mi
Sponsor: Children's Oncology Group
Current Primary Outcome: Progression-free survival (PFS) [ Time Frame: From diagnosis to the earliest of disease progression or death from any cause, assessed at 2 years ]
Original Primary Outcome:
- PFS [ Time Frame: From diagnosis to the earliest of disease progression or death from any cause, assessed at 2 years ]At the time of the final analysis, 95% exact confidence interval estimate of the binomial probability of completing two years of therapy free of failure will be calculated. In addition Kaplan-Meier estimates of PFS and distributions will be provided.
- Overall survival [ Time Frame: From diagnosis to death from any cause, assessed up to 72 months ]Kaplan-Meier estimates of overall survival distributions will be provided.
- Event-free survival [ Time Frame: Up to 72 months ]
- Response rates [ Time Frame: At 189 days ]Estimates of response rates as well as the associated exact confidence intervals will be reported.
- Response rates [ Time Frame: At 273 days ]Estimates of response rates as well as the associated exact confidence intervals will be reported.
Current Secondary Outcome:
- Overall Survival [ Time Frame: From diagnosis to death from any cause, assessed up to 72 months ]Kaplan-Meier estimates of overall survival distributions will be provided.
- Event-free survival [ Time Frame: Up to 72 months ]
- Response [ Time Frame: At 273 days ]Estimates of response rates as well as the associated exact confidence intervals will be reported.
Original Secondary Outcome:
Information By: Children's Oncology Group
Dates:
Date Received: December 13, 2013
Date Started: December 2013
Date Completion:
Last Updated: May 15, 2017
Last Verified: May 2017
