Completed

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

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What is being tested

Sargramostim

+ cyclophosphamide

+ melphalan

BiologicalDrugProcedure
Who is being recruted

Brain Diseases+14

+ Central Nervous System Diseases

+ Glioma

From 2 to 25 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 1994
See protocol details

Summary

Principal SponsorChildren's Oncology Group
Last updated: July 24, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1994

Actual date on which the first participant was enrolled.

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.

NCT00002594
Principal SponsorChildren's Oncology Group
Last updated: July 24, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

31 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 2 to 25 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesGliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNervous System DiseasesNervous System NeoplasmsNeuroectodermal TumorsNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialBrain NeoplasmsMedulloblastomaCentral Nervous System Neoplasms

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 118 locations

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, United StatesOpen University of Alabama at Birmingham Comprehensive Cancer Center in Google Maps

University of South Alabama Medical Center

Mobile, United States

Arizona Cancer Center

Tucson, United States

University of Arkansas for Medical Sciences

Little Rock, United States
Completed118 Study Centers