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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

Phase II Pre-Irradiation Chemotherapy for Central Nervous System Germ Cell Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002472
• Other study ID #: CDR0000076756
• Secondary ID: P30CA01508389135
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: March 14, 2011
• Start date: March 1991
• Est. completion date: August 2005

Study information

• Verified date: March 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• cisplatin

• etoposide

Procedure:
• conventional surgery

• neoadjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate			No
Primary	Survival			No
Primary	Endocrine and cognitive function			No