Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 416 participants |
| Start Date | 2003-08 |
| Est. Completion | 2023-12-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00085202
The ClinicalTrials.gov registry entry for NCT00085202 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 416 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 174-participant average among 45 other Brain and Central Nervous System Tumors trials with a reported enrollment target (139% higher). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
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 reports 9 study locations spanning 8 distinct geographic areas - top geographies include 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.
-
Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma
ACTIVE NOT RECRUITING · Phase 3
-
Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH)
ACTIVE NOT RECRUITING · Phase 3
-
Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma
ACTIVE NOT RECRUITING · Phase 3
-
SU-101 Compared With Procarbazine in Treating Patients With Glioblastoma Multiforme
COMPLETED · Phase 3
-
Opioid Titration Order Sheet or Standard Care in Treating Patients With Cancer Pain
COMPLETED · Phase 3
-
Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas
COMPLETED · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.