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NCT00085202 · ClinicalTrials.gov registry record · Phase 3

Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor

A Phase 3 study of Brain and Central Nervous System Tumors, sponsored by St. Jude Children's Research Hospital.

Completed
Registry status
Phase 3
Development phase
416
Enrollment target
9
Study locations

NCT00085202: Completed Phase 3 study of Brain and Central Nervous System Tumors, sponsored by St. Jude Children's Research Hospital.

NCT00085202 is a Phase 3 study of Brain and Central Nervous System Tumors that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 416 participants, above the 174-participant average among 45 other Brain and Central Nervous System Tumors trials with a reported enrollment target (139% higher). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00085202, a Phase 3 study of Brain and Central Nervous System Tumors, has completed, sponsored by St. Jude Children's Research Hospital.

COMPLETED
Registry status
Phase 3
Development phase
416 participants
Enrollment target
9
Study locations

Study Summary

Drugs used in chemotherapy, such as vincristine, cisplatin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. It is not yet known which radiation therapy regimen combined with chemotherapy and donor stem cell transplant is more effective in treating medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor. This phase III trial is studying two different regimens of radiation therapy when given together with chemotherapy and autologous stem cell transplant to see how well they work in treating patients with newly diagnosed medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor. PRIMARY OBJECTIVE: * To assess the relationship between ERBB2 protein expression in tumors and progression-free survival probability for patients with medulloblastoma. * To estimate the frequency of mutations associated with SHH and WNT tumors (as defined by gene expression profiling) via targeted sequencing performed in an independent cohort of WNT and SHH tumors (also defined by gene expression profiling).

Primary Outcome

The relationship between ERBB2 protein expression in tumors and progression-free survival was assessed in 122 participants with a diagnosis of medulloblastoma and with ERBB2 protein assessments. If the ERBB2 value was greater than zero, the ERBB2 was defined as positive for the participant. If the ERBB2 value was zero, the ERBB2 was defined as negative. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date o

Conditions Studied

Brain and Central Nervous System Tumors

Interventions

  • DRUG cisplatin
  • DRUG cyclophosphamide
  • PROCEDURE autologous hematopoietic stem cell transplantation
  • DRUG vincristine
  • BIOLOGICAL filgrastim

Study Locations (9)

New South Wales

  • Sydney Children's Hospital - Randwick
  • Children's Hospital at Westmead - Westmead

North Carolina

  • Duke Comprehensive Cancer Center - Durham

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia

Tennessee

  • St. Jude Children's Research Hospital - Memphis

Texas

  • Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital - Houston

Queensland

  • Lady Cilento Children's Hospital, Brisbane - Brisbane

Victoria

  • Royal Children's Hospital - Parkville

Ontario

  • Hospital for Sick Children - Toronto

Trial Details

FieldValue
Enrollment Target 416 participants
Start Date 2003-08
Est. Completion 2023-12-31
Phase Phase 3
St. Jude Children's Research Hospital

410 total trials

What the finished NCT00085202 record still lists

NCT00085202 is an interventional study that assigns participants to a tested intervention. The registered 416 participants enrollment target is mid-sized for trials with a published cap, above the 174-participant average among 45 other Brain and Central Nervous System Tumors trials with a reported enrollment target (139% higher).

The record links to 1 condition, with Brain and Central Nervous System Tumors appearing as the primary indexed condition, and to 5 interventions - of which cisplatin is the first listed.

NCT00085202 lists 9 locations in 8 states (New South Wales, North Carolina, Pennsylvania).

Frequently Asked Questions

What is clinical trial NCT00085202 about?

NCT00085202 is a clinical study titled "Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor". Drugs used in chemotherapy, such as vincristine, cisplatin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor c...

What is the current status of trial NCT00085202?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 416 participants. The study started on 2003-08. Estimated completion is 2023-12-31.

What conditions does trial NCT00085202 study?

This clinical trial studies the following conditions: Brain and Central Nervous System Tumors.

What interventions are being tested in trial NCT00085202?

The interventions under investigation include: cisplatin (DRUG), cyclophosphamide (DRUG), autologous hematopoietic stem cell transplantation (PROCEDURE), vincristine (DRUG), filgrastim (BIOLOGICAL).

Who is sponsoring clinical trial NCT00085202?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00085202 being conducted?

This trial has 9 study locations across North Carolina, Pennsylvania, Tennessee, Texas, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Brain and Central Nervous System Tumors

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00085202's enrollment target sits among peer trials

416 5th of 45 higher than 41 of 45 other Brain and Central Nervous System Tumors trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Brain and Central Nervous System Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00085202, the US trial registry maintained by the National Library of Medicine. NCT00085202 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.