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


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Paul L. Moots, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000066256

NCT ID:

NCT00003309

Start Date:

July 1998

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult medulloblastoma
  • adult anaplastic ependymoma
  • adult ependymoma
  • adult supratentorial primitive neuroectodermal tumor (PNET)
  • Ependymoma
  • Medulloblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611