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Completed

NCT Number: NCT00003309

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

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.

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

filgrastim

Biological

Cisplatin

Drug

Cyclophosphamide

Drug

etoposide

Drug

vincristine sulfate

Drug

adjuvant therapy

Procedure

radiation therapy

Radiation

Sponsors and collaborators

Lead sponsor

Eastern Cooperative Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)
  • SWOG Cancer Research Network

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2004
First posted
Jan 27, 2003
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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