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Completed

NCT Number: NCT00002594

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sargramostim

Biological

Given IV

Other names: M-CSF, GM-CSF, Granulocyte macrophage-colony stimulating factor, Prokine, Leukine, NSC #6137

Cyclophosphamide

Drug

Given IV

Other names: Cytoxan, NSC #026271, IND #7089

melphalan

Drug

Given IV

Other names: ylalanine mustard, L-PAM, L-sarcolysin, Alkeran, NSC #8806

autologous bone marrow transplantation

Procedure

bone marrow ablation with stem cell support

Procedure

peripheral blood stem cell transplantation

Procedure

Primary outcomes

  1. Progression-free survival

    Time frame: 1-2 years

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Dose-Intensive Melphalan and Cyclophosphamide With Autologous Bone Marrow Rescue for Recurrent Medulloblastoma and Germ Cell Tumors

Important dates

Study start
1994
Primary completion
2003
Study completion
2007
First posted
Jan 27, 2003
Registry last updated
Jul 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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