Combination Chemotherapy Plus Radiation Therapy in Treating Adult Patients With Brain Cancer

Brain and Central Nervous System Tumors Clinical Trial

Official title:

A Phase II Trial of Preradiation Multiagent Chemotherapy for Adults With "Poor Risk" Medulloblastoma, PNET, and Disseminated Ependymoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003309
• Other study ID #: CDR0000066256
• Secondary ID: E4397SWOG-E4397
• Status: Completed
• Phase: Phase 2
• Start date: May 4, 1999

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 and 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 adult patients with brain cancer.

Description:

OBJECTIVES:

• Determine the complete and partial response rate of patients with adult medulloblastoma, primitive neuroectodermal tumor, or disseminated ependymoma treated with preradiation combination chemotherapy.

• Determine the progression free survival and overall survival of these adult patients treated with combination chemotherapy followed by craniospinal radiation.

• Determine the toxic effects associated with this treatment in these patients.

OUTLINE: Patients receive cisplatin IV over 6 hours, etoposide IV, and vincristine IV over 1-2 minutes on day 1; etoposide IV and cyclophosphamide IV over 1-2 hours on days 2-3; filgrastim (G-CSF) subcutaneously (SC) on days 4-13; and vincristine IV over 1-2 minutes on day 15. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Within 4-6 weeks after the last chemotherapy course, patients undergo radiotherapy 5 days a week for 6 to 7 weeks.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5-10 years.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study within 3 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed central nervous system cancer including:

• Medulloblastoma with either local residual disease of greater than 1 cm^2 on MRI following resection or evidence of metastases (M1-4)

• Other primitive neuroectodermal tumors

• Ependymoma with evidence of subarachnoid metastases

• Must have less than 1 cm of midline shift or no acute elevated intercranial pressure

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 4,000/mm^3

• Platelet count greater than 125,000/mm^3

• Hemoglobin greater than 10 g/dL

• No preexisting hematologic condition that would increase toxicity or limit ability to comply with evaluations and follow-up

Hepatic:

• Bilirubin less than 2 times upper limit of normal (ULN)

• SGOT less than 2 times ULN

• Alkaline phosphatase less than 2 times ULN

• No preexisting hepatic condition that would increase toxicity or limit ability to comply with evaluations and follow-up

Renal:

• Creatinine greater than 70 mL/min

• No preexisting renal condition that would increase toxicity or limit ability to comply with evaluations and follow-up

Pulmonary:

• No history of significant pulmonary disease or, if there is preexisting pulmonary disease, then DLCO greater than 60% of predicted

• No preexisting pulmonary condition that would increase toxicity or limit ability to comply with evaluations and follow-up

Other:

• No preexisting psychiatric condition that would increase toxicity or limit ability to comply with evaluations and follow-up

• No prior or concurrent malignancies within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• No increasing doses of steroids for intracranial disease within 3 days of registration

Radiotherapy:

• No prior radiotherapy

Surgery:

• 10-28 days since prior surgical resection OR

• At least 5 days since prior biopsy

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Ependymoma
• Medulloblastoma
• Nervous System Neoplasms

Intervention

Biological:
• filgrastim

Drug:
• cisplatin

• cyclophosphamide

• etoposide

• vincristine sulfate

Procedure:
• adjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	Veterans Affairs Medical Center - Lakeside Chicago	Chicago	Illinois
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center	Nashville	Tennessee
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI), SWOG Cancer Research Network

Country where clinical trial is conducted

United States, 

References & Publications (1)

Moots PL, O'Neill A, Barger GR, et al.: Toxicities associated with chemotherapy followed by craniospinal radiation for adults with poor-risk medulloblastoma/PNET and disseminated ependymoma: a preliminary report of ECOG 4397. [Abstract] J Clin Oncol 22 (S