Clinical Trial: Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors

This study is currently recruiting patients.

Sponsors and Collaborators: Mayo Clinic Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of cisplatin and etoposide in treating patients with CNS tumors.

Condition Treatment or Intervention Phase
childhood central nervous system germ cell tumor
extragonadal germ cell tumor
adult central nervous system germ cell tumor
childhood mature and immature teratomas
 Drug: cisplatin
 Drug: etoposide
 Procedure: chemotherapy
 Procedure: conventional surgery
 Procedure: neoadjuvant therapy
 Procedure: radiation therapy
 Procedure: surgery
Phase II

MedlinePlus related topics:  Brain Cancer;   Cancer;   Cancer Alternative Therapy;   Endocrine Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Neoadjuvant Chemotherapy With Cisplatin and Etoposide Followed by Radiotherapy in Patients With CNS Germ Cell Malignancies

Further Study Details: 

OBJECTIVES:

  • Determine the response rate of patients with newly diagnosed CNS germ cell tumors treated with cisplatin and etoposide.
  • Determine the survival of patients with CNS germ cell tumors treated with cisplatin and etoposide followed by cranial radiotherapy.
  • Determine endocrine and cognitive function in these patients before and after receiving this regimen.

OUTLINE: Patients are stratified by histology (germinoma vs nongerminoma).

Patients receive cisplatin IV over 4 hours followed by etoposide IV over 30-60 minutes on days 1-5. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of 4 courses, patients with nongerminoma who achieve complete response (CR) and all patients with germinoma proceed to radiotherapy. After completion of 4 courses, patients with nongerminoma who achieve less than CR undergo resection of any residual cranial masses, if feasible, and then proceed to radiotherapy. Patients who experience disease progression or unacceptable toxicity during chemotherapy are restaged and proceed directly to radiotherapy.

Beginning a minimum of 3 weeks after completion of the last course of chemotherapy and after recovering from any toxic effects of chemotherapy, eligible patients undergo a regimen of craniospinal axis irradiation and/or localized cranial or spinal field irradiation based on histology, extent of disease, and response to chemotherapy. Patients with gross spinal meningeal disease after completion of chemotherapy undergo radiotherapy boost.

Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 12-25 patients with germinoma will be accrued for this study within 3-6 years. A total of 12-25 patients with nongerminoma will be accrued for this study within 6-12 years.

Eligibility

Ages Eligible for Study:  3 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age:

  • 3 and over

Hematopoietic:

  • Age 18 and over:
  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Under age 18:
  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Not specified

Renal:

  • Creatinine no greater than 0.3 mg/dL above upper limit of normal for age

Other:

  • No uncontrolled infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • Not specified

Chemotherapy:

Endocrine therapy:

  • Concurrent corticosteroids allowed except as antiemetics

Radiotherapy:

  • No prior cranial or spinal radiotherapy

Surgery:

  • Not specified

Location and Contact Information


Arizona
      Mayo Clinic Scottsdale, Scottsdale,  Arizona,  85259,  United States; Recruiting
Tom Robert Fitch, MD  480-301-8335 

Florida
      Mayo Clinic - Jacksonville, Jacksonville,  Florida,  32224,  United States; Recruiting
Kurt A. Jaeckle, MD  904-953-7102 

Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
Jan C. Buckner, MD  507-284-4320 

Study chairs or principal investigators

Jan C. Buckner, MD,  Study Chair,  Mayo Clinic Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000076756; MAYO-891351; NCI-T92-0208D; NCT00002472
Record last reviewed:  September 2003
Last Updated:  January 6, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002472
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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