search
Back to results

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

Primary Purpose

Brain and Central Nervous System Tumors, Pediatric Germ Cell Tumor, Extragonadal Germ Cell Tumor

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cisplatin
etoposide
conventional surgery
neoadjuvant therapy
radiation therapy
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring 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

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Scottsdale
  • Mayo Clinic - Jacksonville
  • Mayo Clinic Cancer Center

Outcomes

Primary Outcome Measures

Response rate
Survival
Endocrine and cognitive function

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
March 14, 2011
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00002472
Brief Title
Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors
Official Title
Phase II Pre-Irradiation Chemotherapy for Central Nervous System Germ Cell Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
March 1991 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Pediatric Germ Cell Tumor, Extragonadal Germ Cell Tumor
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Response rate
Title
Survival
Title
Endocrine and cognitive function

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan C. Buckner, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs