Los Angeles, California 90027

  • Brain and Central Nervous System Tumors

Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating patients who have surgically resected, newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumor, or incompletely resected ependymoma.


Study summary:

OBJECTIVES: - Determine the toxicity of adjuvant dose-intensive induction chemotherapy with cisplatin, vincristine, cyclophosphamide, and etoposide with or without methotrexate followed by standard radiotherapy in patients with surgically resected, newly diagnosed high stage medulloblastoma or supratentorial primitive neuroectodermal tumor, or incompletely resected ependymoma. - Determine the response rate, time to progression, overall survival, and pattern of failure in these patients treated with this regimen. OUTLINE: Patients receive dose-intensive induction chemotherapy consisting of cisplatin IV over 6 hours on day 0; vincristine IV on days 0, 7, and 14; and etoposide and cyclophosphamide IV over 1 hour on days 1 and 2. Patients with M1+ disease (i.e., evidence of dissemination beyond primary tumor site) also receive methotrexate IV over 4 hours on day 3. Patients receive filgrastim (G-CSF) subcutaneously daily beginning on day 7 and continuing until blood counts recover. Chemotherapy continues every 21-28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo radiotherapy 5 days a week for 6.5 weeks beginning 3-6 weeks after completion of chemotherapy. Patients are followed at 6 weeks, then every 3 months for 2 years, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 6-20 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histological confirmation of one of the following: - High stage medulloblastoma with neuraxis dissemination (Chang stage M1 or greater) - Primitive neuroectodermal tumor - Ependymoma - Incompletely resected on postoperative MRI or neurosurgical report - Definitive prior surgery within 42 days of study PATIENT CHARACTERISTICS: Age: - 10 to 65 Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin less than 1.5 mg/dL - SGPT less than 2.5 times upper limit of normal Renal: - Creatinine clearance greater than 60 mL/min PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Prior corticosteroids allowed - No concurrent corticosteroids as antiemetics Radiotherapy: - No prior radiotherapy Surgery: - See Disease Characteristics


Study is Available At:


Original ID:

CHLA-NYU-0002H


NCT ID:

NCT00006258


Secondary ID:

CDR0000068192


Study Acronym:


Brief Title:

Combination Chemotherapy Followed by Radiation Therapy in Treating Patients With Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or E


Official Title:

Dose Intensive Chemotherapy for Patients Greater Than or Equal To 10 Years of Age With Newly Diagnosed High Stage Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumors (PNET) and Ependymoma: A Feasibility Study of an Intensive Induction Chemoth


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

10 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Jonathan L. Finlay, MB, ChB
Study Chair
Children's Hospital Los Angeles

Study Dates

Start Date:November 1997
Completion Date:January 2005
Completion Type:Actual
Verification Date:December 2004
Last Changed Date:July 17, 2013
First Received Date:September 11, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:filgrastim
Intervention Type:Drug
Name:cisplatin
Intervention Type:Drug
Name:cyclophosphamide
Intervention Type:Drug
Name:etoposide
Intervention Type:Drug
Name:methotrexate
Intervention Type:Drug
Name:vincristine sulfate
Intervention Type:Procedure
Name:adjuvant therapy
Intervention Type:Radiation
Name:radiation therapy

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Children's Hospital Los Angeles
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Dhodapkar K, Dunkel IJ, Gardner S, Sapp M, Thoron L, Finlay J. Preliminary results of dose intensive pre-irradiation chemotherapy in patients older than 10 years of age with high risk medulloblastoma and supratentorial primitive neuroectodermal tumors. Med Pediatr Oncol. 2002 Jan;38(1):47-8. No abstract available.
PMID:11835236

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.