Clinical trial · Interventional
Combination Chemotherapy With or Without Etoposide Followed By an Autologous Stem Cell Transplant in Treating Young Patients With Previously Untreated Malignant Brain Tumors
Dose Intensive Chemotherapy for Children Less Than Ten Years of Age Newly-Diagnosed With Malignant Brain Tumors: A Pilot Study of Two Alternative Intensive Induction Chemotherapy Regimens, Followed by Consolidation With Myeloablative Chemotherapy (Thiotepa and Carboplatin, With or Without Etoposide) and Autologous Stem Cell Rescue [HEAD START III]
- 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)
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A bone marrow or peripheral stem cell transplant using stem cells from the patient may be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more tumor cells are killed. PURPOSE: This phase III trial is studying how well giving combination chemotherapy with or without etoposide followed by an autologous stem cell transplant works in treating young patients with previously untreated malignant brain tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous bone marrow transplantation | Procedure | — | UNRESOLVED |
| autologous hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Regimen C
- description
- Patients receive induction therapy of vincristine IV on days 1, 8, and 15 of courses 1-3, oral temozolomide once daily on days 1-5, and carboplatin IV over 4 hours on days 1 and 2. Patients also receive G-CSF SC beginning on day 6 and continuing until blood counts recover. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients receive consolidation therapy of carboplatin IV over 4 hours on days -8 to -6 and thiotepa IV over 3 hours on days -5 to -3, undergo reinfusion of bone marrow or peripheral blood stem cells on day 0, and receive G-CSF SC beginning on day 1 and continuing until blood counts recover. Beginning within 6 weeks after transplantation, some patients undergo radiotherapy once daily 5 days a week for 4-6 weeks in the absence of disease progression or unacceptable toxicity and some patients undergo radiotherapy if there is evidence of tumor remaining after completion of induction chemotherapy.
- interventionNames
- Drug: carboplatin
- Drug: temozolomide
- Drug: thiotepa
- Drug: vincristine sulfate
- Procedure: autologous bone marrow transplantation
- Procedure: autologous hematopoietic stem cell transplantation
- Procedure: peripheral blood stem cell transplantation
- Radiation: radiation therapy
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 10 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed malignant brain tumor, including any of the following:
* Posterior fossa medulloblastoma/primitive neuroectodermal tumor (PNET)\*
* All stages allowed
* Must be \< 4 years of age at diagnosis unless there is evidence of postoperative residual tumor (\> 1.5 cm² tumor area) or evidence of neuraxis or extraneural dissemination (high-stage)
* Medulloblastoma, cerebral neuroblastoma, and ependymoblastoma allowed
* Low-stage (standard-risk) medulloblastoma not allowed in patients \> 4 years of age
* Ependymoma\*
* All stages and locations allowed
* Cellular and anaplastic subtypes allowed (no myxopapillary ependymomas of the spinal cord)
* Must be \< 36 months of age at diagnosis for posterior fossa tumor OR \< 72 months of age for supratentorial tumor
* Evidence of neuraxis dissemination irrespective of primary site
* No cellular (low-grade) supratentorial ependymomas at any age with complete resection of parenchymally based (i.e., not periventricular) supratentorial tumors
* Brain stem tumor\*
* All stages allowed irrespective of extent of resection
* No unbiopsied diffuse intrinsic pontine tumor
* Tumor pathologically confirmed to be either malignant glioma or PNET allowed
* High-grade glioma\*\*
* Primary atypical teratoid/rhabdoid tumor of the CNS\*
* Choroid plexus carcinoma or atypical choroid plexus papilloma\*
* All stages and locations allowed
* Anaplastic astrocytoma\*\*
* Glioblastoma multiforme\*\*
* Anaplastic oligodendroglioma\*\*
* Anaplastic ganglioglioma\*\*
* Other anaplastic mixed gliomas\*\*
* Small-cell glioblastoma\*\*
* Giant-cell glioblastoma\*\*
* Gliosarcoma\*\*
* The following diagnoses or subtypes are not allowed:
* Choroid plexus papilloma
* Pineocytoma
* Low-grade mixed glioma
* Primary CNS germ cell tumor
* Primary CNS lymphoma
* Solid leukemic lesions (i.e., chloromas, granulocytic sarcomas)
* Pleomorphic xanthoastrocytoma, low grade
* Desmoplastic ganglioglioma
* Low-grade astrocytoma
* Previously untreated disease
* Has undergone definitive surgery within the past 42 days NOTE: \*Patients receive treatment according to regimen D2
NOTE: \*\*Patients receive treatment according to regimen C
PATIENT CHARACTERISTICS:
* Bilirubin \< 1.5 mg/dL
* ALT and AST \< 2.5 times upper limit of normal
* Creatinine clearance and/or glomerular filtration rate ≥ 60 mL/min
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior radiotherapy or chemotherapy
* Prior corticosteroids allowed
* No concurrent corticosteroids for antiemesis only
* No concurrent brachytherapy or electron radiotherapy
* No concurrent dairy products or grapefruit juice with temozolomide administrationReferences
Publications (0)
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