Clinical trial · Interventional
Stem Cell Transplant for High Risk Central Nervous System (CNS) Tumors
Phase II Prospective Study of Sequential Myeloablative Chemotherapy With Stem Cell Rescue for the Treatment of Selected High Risk CNS Tumors and Recurrent CNS Tumors
NCT00179803CI-TRIAL-00046436completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary goal of this study is to determine if a stem cell transplant in patients with newly diagnosed high risk CNS tumors (glioblastoma multiforme \[GBM\], high grade astrocytoma, pineoblastoma, rhabdoid tumor, supratentorial primitive neuroectodermal tumor \[PNET\]) increases overall survival.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytoma | Astrocytoma | CURATED_BROADER | 0.80 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Pineoblastoma | Pineoblastoma | ONTOLOGY_EXACT | 0.98 |
| Rhabdoid Tumor | Rhabdoid Tumor | ONTOLOGY_EXACT | 0.98 |
| Supratentorial Neoplasms | Supratentorial Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stem Cell Transplant | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- high dose chemotherapy
- interventionNames
- Procedure: Stem Cell Transplant
Primary outcomes (1)
- measure
- To determine if the use of sequential myeloablative chemotherapy with peripheral blood stem cell rescue will increase the overall survival rate in patients with newly diagnosed high risk CNS tumors
- timeFrame
- To end of study
Secondary outcomes (4)
- measure
- The overall survival and progression free survival in children with recurrent CNS malignancies after obtaining a state of minimum residual disease with submyeloablative chemotherapy, surgery, and/or radiation.
- timeFrame
- To end of study
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Months
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * Patient's age must be greater than (\>) 18 months and less than or equal to (≤) 25 years at the time of diagnosis or recurrence. * Neuroradiographic evidence of a recurrent posterior fossa medulloblastoma or recurrent CNS germ cell tumor. * The presence of a histologically confirmed high grade astrocytoma, GBM, rhabdoid tumor, supratentorial PNET, or pineoblastoma either at the time of diagnosis or recurrence. * Patients must be brought to state of minimum residual disease by surgical reduction and/or chemotherapy and/or radiation therapy or a combination of above prior to myeloablative chemotherapy and tandem stem cell rescue. * Documentation of chemotherapy sensitivity is required for enrollment. Chemotherapy-sensitive tumors are defined as those tumors which have had a reduction of 50% after 2-4 cycles of chemotherapy (CTX or platinum). For patients with no evidence of disease post resection, continued complete remission after 2-4 cycles of chemotherapy defines chemosensitivity. * Adequate physiologic function, defined as follows: * creatinine clearance \> 70 ml/minutes/1.73 m2. * SGPT \< 10 x normal and bilirubin \< 10 mg/dl. * Adequate complete blood count (CBC): hemoglobin \> 10 gm/dl, absolute neutrophil count (ANC) \> 1500/ul, and platelets \> 100,000/ul. * Informed consent. The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained, in accordance with institutional policies provided by the United States (U.S.) Department of Health and Human Services. * Protocol approval. Approval for the use of this institution's Human Rights Committee must be obtained in accordance with the institutional assurance policies of the U. S. Department of Health and Human Services. * Patients with high-risk medulloblastoma after initial surgery. * To allow non-English speaking patients to participate in this study, bilingual health care services will be provided in the appropriate language. Exclusion Criteria: * Patients with brain stem glioma are ineligible.
References
Publications (0)
Data not yet available
No reference posted for this study.