Completed

Cisplatin and Etoposide Chemotherapy for Central Nervous System Germ Cell Malignancies

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Study Aim

This phase 2 study aims to evaluate the response rate, survival, and endocrine and cognitive function in individuals undergoing Cisplatin and Etoposide chemotherapy treatment for Central Nervous System Germ Cell Malignancies.

What is being tested

cisplatin

+ etoposide

+ conventional surgery

DrugProcedureRadiation
Who is being recruted

Neoplasms+5

+ Neoplasms by Histologic Type

+ Neoplasms by Site

Over 3 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 1991
See protocol details

Summary

Principal SponsorMayo Clinic
Last updated: March 15, 2011
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 1991

Actual date on which the first participant was enrolled.

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.

NCT00002472
Principal SponsorMayo Clinic
Last updated: March 15, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 3 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNervous System DiseasesNervous System NeoplasmsTeratomaCentral Nervous System Neoplasms

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Mayo Clinic Scottsdale

Scottsdale, United StatesOpen Mayo Clinic Scottsdale in Google Maps

Mayo Clinic - Jacksonville

Jacksonville, United States

Mayo Clinic Cancer Center

Rochester, United States
Completed3 Study Centers