Clinical trial · Interventional
Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors
Dose-Intensive Melphalan and Cyclophosphamide With Autologous Bone Marrow Rescue for Recurrent Medulloblastoma and Germ Cell Tumors
- 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 use different ways to stop tumor cells from dividing so that they stop growing or die. bone marrow transplantation and peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow transplantation and/or peripheral stem cell transplantation in treating patients who have recurrent medulloblastoma or CNS germ cell tumors.
Conditions
Conditions (2)
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 Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Central Nervous System Tumor | Central Nervous System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous bone marrow transplantation | Procedure | — | UNRESOLVED |
| bone marrow ablation with stem cell support | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| Sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ablative chemo followed by autologous bone marrow (ABM) rescue
- description
- Autologous bone marrow and/or peripheral blood stem cells (PBSC) are harvested. Patients then receive intensive cyclophosphamide IV over 1 hour on days -8 to -5 and melphalan IV over 15 minutes on days -4 to -2. Bone marrow is reinfused on day 0. PBSC are reinfused on day 0 if used alone or on day 1 if used after autologous bone marrow transplantation (ABMT). Sargramostim (GM-CSF) is administered IV over 2 hours daily beginning 4 hours after ABMT and continuing until blood counts recover.
- interventionNames
- Biological: Sargramostim
- Drug: cyclophosphamide
- Drug: melphalan
- Procedure: autologous bone marrow transplantation
- Procedure: bone marrow ablation with stem cell support
- Procedure: peripheral blood stem cell transplantation
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 1-2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 25 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of recurrent medulloblastoma or CNS germ cell tumor
* Histologic review of the primary intracranial or spinal cord tumor required
* Biopsy and reduction of tumor bulk prior to study encouraged but not required
* No more than 1 prior primary therapy (radiotherapy or chemoradiotherapy) and/or 1 prior salvage therapy
* Patients with progression on salvage therapy ineligible
* Minimal residual disease (tumor bulk no more than 1.5 cm) or in second clinical complete remission (CR)
* Bone marrow infiltration with or without mass lesions or isolated abnormal CSF cytology as the only manifestation of recurrent disease allowed if a clinical CR is first achieved with conventional therapy
PATIENT CHARACTERISTICS:
Age:
* 2 to 25
Performance status:
* Karnofsky 80-100%
Life expectancy:
* More than 8 weeks
Hematopoietic:
* Absolute neutrophil count greater than 1,000/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic:
* Bilirubin less than 1.5 mg/dL
* SGPT less than 80 IU
Renal:
* Creatinine less than 1.2 mg/dL
Cardiovascular:
* LVEF normal
Other:
* No infection
* Able to tolerate vigorous hydration
* Not pregnant
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* Prior cyclophosphamide or ifosfamide allowed
Endocrine therapy:
* No concurrent dexamethasone as an antiemetic
* Other concurrent corticosteroids allowed
Radiotherapy:
* See Disease Characteristics
* Pretransplantation radiotherapy boost allowed
Surgery:
* See Disease Characteristics
* Pretransplantation surgery allowed
Other:
* At least 4 weeks since prior therapy except corticosteroidsReferences
Publications (1)
- RESULTKadota RP, Mahoney DH, Doyle J, Duerst R, Friedman H, Holmes E, Kun L, Zhou T, Pollack IF. Dose intensive melphalan and cyclophosphamide with autologous hematopoietic stem cells for recurrent medulloblastoma or germinoma. Pediatr Blood Cancer. 2008 Nov;51(5):675-8. doi: 10.1002/pbc.21655. PMID 18623206