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Phase II Study of Vincristine, Methotrexate, Carboplatin, Cyclophosphamide, and Cisplatin With or Without Radiotherapy in Children With Primary Brain or Brain Stem Tumors

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy With or Without Radiation Therapy in Treating Children With Brain Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Closed Under 3 Other CCLG-CNS-9204
EU-20574, NCT00281905, CCLG-CNS-1992-04

Objectives

Determine the response rate in children under 36 months of age with primary brain or brain stem tumors treated with vincristine, methotrexate, carboplatin, cyclophosphamide, and cisplatin with or without radiotherapy.
Determine the event-free survival and overall survival in children treated with this regimen.
Determine the pattern of local recurrence or occurrence of CNS metastases in children treated with this regimen.
Determine the quality of life in children treated with this regimen.
Determine the tolerability and long-term toxicity of this regimen in these children.
Determine the proportion of children who require radiotherapy after treatment with this regimen.
Determine the prognosis of children who receive both chemotherapy and radiotherapy.
Determine the nature and behavior of brain tumors in very young children.

Entry Criteria

Disease Characteristics:

Diagnosis of 1 of the following:
- Brain stem tumor (histological confirmation not required)
- Histologically confirmed primary intracranial brain tumor of 1 of the following histologies:
  - Anaplastic (malignant) astrocytoma
  - Glioblastoma
  - Anaplastic (malignant) oligodendroglioma
  - Ependymoma
  - Anaplastic (malignant) ependymoma
  - Anaplastic (malignant) oligoastrocytoma
  - Choroid plexus carcinoma
  - Astroblastoma
  - Polar spongioblastoma
  - Gliomatosis cerebri
  - Anaplastic (malignant) ganglioglioma
  - Pineoblastoma
  - Mixed pineocytoma or pineoblastoma
  - Medulloepithelioma
  - Neuroblastoma
  - Ependymoblastoma
  - Primitive neuroectodermal tumors (PNETs), including medulloblastoma or cerebral or spinal PNETs

Has undergone surgery or biopsy of the tumor within the past 2-4 weeks

Prior/Concurrent Therapy:

No prior chemotherapy or radiotherapy
Prior steroids allowed
No concurrent steroids as anti-emetics
- Concurrent steroids allowed for control of tumor-related symptoms

Patient Characteristics:

No concurrent unrelated disease, including hematological or renal disease, that would preclude study treatment

Expected Enrollment

A total of 50 patients will be accrued for this study.

Outcomes

Primary Outcome(s)

Response rate
Event-free survival
Local recurrence or occurrence of CNS metastases
Quality of survival
Tolerance
Long-term toxicity
Proportion of patients requiring radiotherapy
Prognosis of children who receive both chemotherapy and radiotherapy
Nature and behavior of brain tumors

Outline

This is a multicenter study.

Chemotherapy: Patients receive vincristine IV on days 0, 14, and 28; carboplatin IV over 4 hours on day 0; methotrexate IV continuously over 24 hours on day 14; cyclophosphamide IV over 4 hours on day 28; and cisplatin IV continuously over 48 hours on days 42 and 43. Courses repeat every 56 days (8 weeks) for up to 12 months. Patients who achieve a complete response proceed to observation, as do those achieving a partial response with no tumor present on biopsy. Patients with biopsy proven residual tumors after 12 months of chemotherapy or recurrent tumors that don't have the potential to spread through the cerebrospinal fluid (CSF) proceed to local radiotherapy. Patients with unresponsive disease or progressive disease that has the potential to spread through the CSF proceed to craniospinal radiotherapy.

Local radiotherapy: Patients undergo local radiotherapy 5 days a week for 5-5½ weeks.

Craniospinal radiotherapy: Patients undergo craniospinal radiotherapy 5 days a week for 4 weeks.

Quality of life is assessed periodically.

After completion of study treatment, patients are followed periodically for at least 2 years.

Trial Contact Information

Trial Lead Organizations

Children's Cancer and Leukaemia Group

Richard Grundy, MD, PhD, Protocol chair
Ph: 44-115-970-9257
Email: richard.grundy@nottingham.ac.uk

Registry Information

Official Title		Management of Children Aged Less Than 3 Years with Brain Tumors

Trial Start Date		1992-06-01

Registered in ClinicalTrials.gov		NCT00281905

Date Submitted to PDQ		2005-09-15

Information Last Verified		2007-06-22

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.