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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00002472
First received: November 1, 1999
Last updated: March 14, 2011
Last verified: March 2011
  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 Intervention Phase
Brain and Central Nervous System Tumors
Pediatric Germ Cell Tumor
Extragonadal Germ Cell Tumor
Drug: cisplatin
Drug: etoposide
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Pre-Irradiation Chemotherapy for Central Nervous System Germ Cell Malignancies

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]
  • Endocrine and cognitive function [ Designated as safety issue: No ]

Study Start Date: March 1991
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Detailed Description:

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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven CNS germ cell tumor of 1 of the following subtypes:

    • CNS germinoma
    • Immature teratoma
    • Embryonal cell carcinoma
    • Yolk sac tumor
    • Endodermal sinus tumor
    • Choriocarcinoma OR
  • Pineal or suprasellar mass associated with elevated CSF alpha fetoprotein or beta-human chorionic gonadotropin allowed
  • Patients 18 years and over with localized pure germinomas ineligible
  • Evaluable CT or MRI of brain and/or spinal cord required

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:

  • No prior chemotherapy for CNS germ cell tumor

Endocrine therapy:

  • Concurrent corticosteroids allowed except as antiemetics

Radiotherapy:

  • No prior cranial or spinal radiotherapy

Surgery:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002472

Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Jan C. Buckner, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Jan C. Buckner , MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00002472     History of Changes
Other Study ID Numbers: CDR0000076756, P30CA015083, 891351, T92-0208D
Study First Received: November 1, 1999
Last Updated: March 14, 2011
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
childhood central nervous system germ cell tumor
extragonadal germ cell tumor
adult central nervous system germ cell tumor
childhood teratoma
childhood central nervous system choriocarcinoma
childhood central nervous system embryonal tumor
childhood central nervous system germinoma
childhood central nervous system mixed germ cell tumor
childhood central nervous system teratoma
childhood central nervous system yolk sac tumor

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Neoplasms
Neoplasms, Germ Cell and Embryonal
Nervous System Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Nervous System Diseases
Cisplatin
Etoposide
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 29, 2014