NCT00002472

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 1991

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1991

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

March 15, 2011

Status Verified

March 1, 2011

Enrollment Period

14.4 years

First QC Date

November 1, 1999

Last Update Submit

March 14, 2011

Conditions

Brain and Central Nervous System TumorsPediatric Germ Cell TumorExtragonadal Germ Cell Tumor

Keywords

childhood central nervous system germ cell tumorextragonadal germ cell tumoradult central nervous system germ cell tumorchildhood teratomachildhood central nervous system choriocarcinomachildhood central nervous system embryonal tumorchildhood central nervous system germinomachildhood central nervous system mixed germ cell tumorchildhood central nervous system teratomachildhood central nervous system yolk sac tumor

Outcome Measures

Primary Outcomes (3)

  • Response rate

  • Survival

  • Endocrine and cognitive function

Interventions

cisplatinDRUG
etoposideDRUG
conventional surgeryPROCEDURE
neoadjuvant therapyPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsTeratoma

Interventions

CisplatinEtoposideNeoadjuvant TherapyRadiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesCombined Modality TherapyTherapeutics

Study Officials

  • Jan C. Buckner, MD

    Mayo Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

March 1, 1991

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

March 15, 2011

Record last verified: 2011-03

Locations

US(3)