Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors
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Keep this study
Lead
Children's Oncology Group
With
National Cancer Institute (NCI)
OBJECTIVES:
* Determine the response and progression-free survival in patients with recurrent medulloblastoma or CNS germ cell tumors treated with intensive melphalan and cyclophosphamide followed by autologous bone marrow and/or peripheral blood stem cell rescue.
* Determine the acute and delayed toxic effects of this regimen in these patients.
OUTLINE: 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.
Patients are followed every 6 months through year 4 and then annually thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2.5 years.
Age
2–25
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 corticosteroids
Clareo Health | Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors