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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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
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 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | DOSE-INTENSIVE MELPHALAN AND CYCLOPHOSPHAMIDE WITH AUTOLOGOUS BONE MARROW RESCUE FOR RECURRENT MEDULLOBLASTOMA AND GERM CELL TUMORS - A PEDIATRIC ONCOLOGY GROUP PILOT STUDY |
| Estimated Enrollment: | 30 |
| Study Start Date: | September 1994 |
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.
Eligibility| Ages Eligible for Study: | 2 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 118 Study Locations| Study Chair: | Donald H. Mahoney, MD | Texas Children's Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00002594 History of Changes |
| Other Study ID Numbers: | CDR0000063784, COG-P9430, POG-9430 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent childhood brain tumor childhood central nervous system germ cell tumor recurrent childhood medulloblastoma |
Additional relevant MeSH terms:
|
Medulloblastoma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Germ Cell and Embryonal Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms by Histologic Type Neoplasms Neuroectodermal Tumors, Primitive Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases |
Cyclophosphamide Melphalan Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |
ClinicalTrials.gov processed this record on May 22, 2013