Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Melphalan; Molgramostim; Sargramostim

Criteria

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