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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00002594




Registration number
NCT00002594
Ethics application status
Date submitted
1/11/1999
Date registered
27/01/2003
Date last updated
24/07/2014

Titles & IDs
Public title
Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors
Scientific title
Dose-Intensive Melphalan and Cyclophosphamide With Autologous Bone Marrow Rescue for Recurrent Medulloblastoma and Germ Cell Tumors
Secondary ID [1] 0 0
COG-P9430
Secondary ID [2] 0 0
9430
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Tumor 0 0
Central Nervous System Tumor 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Testicular
Cancer 0 0 0 0
Other cancer types
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Children's - Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Sargramostim
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - melphalan
Treatment: Surgery - autologous bone marrow transplantation
Treatment: Surgery - bone marrow ablation with stem cell support
Treatment: Surgery - peripheral blood stem cell transplantation

Experimental: Ablative chemo followed by autologous bone marrow (ABM) rescue - 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.


Other interventions: Sargramostim
Given IV

Treatment: Drugs: cyclophosphamide
Given IV

Treatment: Drugs: melphalan
Given IV

Treatment: Surgery: autologous bone marrow transplantation


Treatment: Surgery: bone marrow ablation with stem cell support


Treatment: Surgery: peripheral blood stem cell transplantation
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival
Timepoint [1] 0 0
1-2 years

Eligibility
Key inclusion 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
Minimum age
2 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/1994
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2007
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 0 0
Royal Children's Hospital - Brisbane
Recruitment hospital [3] 0 0
Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
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Arkansas
Country [4] 0 0
United States of America
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California
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United States of America
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Connecticut
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Hawaii
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United States of America
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Illinois
Country [11] 0 0
United States of America
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Kansas
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United States of America
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Louisiana
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United States of America
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Maine
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Mississippi
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Missouri
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New Hampshire
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United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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Oklahoma
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Oregon
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Pennsylvania
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United States of America
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Rhode Island
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
Country [31] 0 0
United States of America
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Vermont
Country [32] 0 0
United States of America
State/province [32] 0 0
Virginia
Country [33] 0 0
United States of America
State/province [33] 0 0
Washington
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United States of America
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West Virginia
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United States of America
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Wisconsin
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Canada
State/province [36] 0 0
Alberta
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Canada
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Ontario
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Canada
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Quebec
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Netherlands
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Groningen
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Puerto Rico
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Santurce
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Switzerland
State/province [41] 0 0
Bern
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Switzerland
State/province [42] 0 0
Geneva

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00002594
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Donald H. Mahoney, MD
Address 0 0
Texas Children's Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00002594