Clinical trial NCT00003309: Combination Chemotherapy Plus Radiation Therapy in Treating Adult Patients With Brain Cancer
Official title: A Phase II Trial of Preradiation Multiagent Chemotherapy for Adults With "Poor Risk" Medulloblastoma, PNET, and Disseminated Ependymoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Keywords: adult medulloblastoma
adult anaplastic ependymoma
adult ependymoma
adult supratentorial primitive neuroectodermal tumor (PNET)
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: SWOG Cancer Research Network
First posted: 2003-01-27
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Chicago
country: United States
facility: Veterans Affairs Medical Center - Lakeside Chicago
state: Illinois
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University
state: Illinois
city: Urbana
country: United States
facility: CCOP - Carle Cancer Center
state: Illinois
city: Cedar Rapids
country: United States
facility: CCOP - Cedar Rapids Oncology Project
state: Iowa
city: Des Moines
country: United States
facility: CCOP - Iowa Oncology Research Association
state: Iowa
city: Wichita
country: United States
facility: CCOP - Wichita
state: Kansas
city: Kalamazoo
country: United States
facility: CCOP - Kalamazoo
state: Michigan
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: Saint Louis Park
country: United States
facility: CCOP - Metro-Minnesota
state: Minnesota
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
state: Tennessee
city: Marshfield
country: United States
facility: CCOP - Marshfield Clinic Research Foundation
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Cancer Center
state: Wisconsin
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Paul L. Moots, MD
role: STUDY_CHAIR
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Larry Kleinberg, MD
role: STUDY_CHAIR
affiliation: Barbara Ann Karmanos Cancer Institute
name: Geoffrey R. Barger, MD
role: STUDY_CHAIR
References:
citation: 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 (Suppl 14): A-1573, 125s, 2004.