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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00003141




Trial ID
NCT00003141
Ethics application status
Date submitted
1/11/1999
Date registered
5/11/2003
Date last updated
27/03/2014

Titles & IDs
Public title
Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Infants With Malignant Brain or Spinal Cord Tumors
Scientific title
A Pilot Study of Intensive Chemotherapy With Peripheral Stem Cell Support for Infants With Malignant Brain Tumors
Secondary ID [1] 0 0
COG-99703
Secondary ID [2] 0 0
99703
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Tumors 0 0
Central Nervous System Tumors 0 0
Neuroblastoma 0 0
Sarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Children's - Other
Cancer 0 0 0 0
Children's - Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - filgrastim
Treatment: Drugs - carboplatin
Treatment: Drugs - cisplatin
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - etoposide
Treatment: Drugs - thiotepa
Treatment: Drugs - vincristine sulfate
Treatment: Surgery - conventional surgery
Treatment: Surgery - peripheral blood stem cell transplantation

Experimental: Treatment (combination chemotherapy, PBSC transplant) - Pts undergo conventional surgery for diagnosis & max tumor resection. In 6 wks of surgery or when stable pts begin induction chemotherapy(cisplatin IV over 6 hrs on day 0; vincristine sulfate IV on days 0,7,14; cyclophosphamide IV over 1 hr on days 1-2; and etoposide IV over 1 hr on days 0-2. 24 hrs after the last cyclophosphamide dose, pts receive filgrastim (G-CSF) & undergo peripheral blood stem cell harvest 2 days later. Treatment repeats every 21 days for up to 3 crs. Within 6 wks after induction, pts receive consolidation (carboplatin IV over 2 hrs on days 0-1 next esc. doses of thiotepa IV over 2 hrs. Pts undergo peripheral blood stem cell transplantation 48 hrs after last thiotepa dose. Pts receive G-CSF SC daily on days 3-21. Treatment repeats every 21 days for up to 3 crs. Pts with dose-limiting toxicity due to thiotepa are removed from study. Pts are followed at 4 wks, 3 mths for 1 yr, 6 mths for 3 yrs, annually for 3 yrs or until relapse.


Other interventions: filgrastim
Given IV

Treatment: Drugs: carboplatin
Given IV

Treatment: Drugs: cisplatin
Given IV

Treatment: Drugs: cyclophosphamide
Given IV

Treatment: Drugs: etoposide
Given IV

Treatment: Drugs: thiotepa
Given IV

Treatment: Drugs: vincristine sulfate
Given IV

Treatment: Surgery: conventional surgery


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
Feasibility - Demonstrate the feasibility of administering this regimen, to select an acceptable Thiotepa dose for Consolidation therapy, and to document significant toxicities and estimate their overall rates
Timepoint [1] 0 0
Up to 4 weeks after completion of study treatment
Primary outcome [2] 0 0
Maximal tolerated dose of thiotepa for consolidation therapy - The dose level will be assigned within 3 working days prior to beginning Consolidation.
Timepoint [2] 0 0
9 weeks
Primary outcome [3] 0 0
Overall rates of significant toxicities including grade IV ototoxicity, electrolytic wasting (grade IV), and hemorrhagic cystitis (grade IV) - Estimates will be obtained using life-table methods with an event defined as the first occurrence of toxicity. Graded using the CCG Toxicity and Complications Criteria.
Timepoint [3] 0 0
Up to 6 years
Secondary outcome [1] 0 0
Event Free Survival
Timepoint [1] 0 0
From the time of study entry to the first occurrence of death by any cause, progression or recurrence of disease or occurrence of a second malignant neoplasm, assessed up

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically proven malignant brain or spinal cord tumor, including the following:

- Primitive neuroectodermal tumor

- Ganglioneuroblastoma

- Medulloblastoma neuroblastoma

- Desmoplastic medulloblastoma

- Medulloepithelioma

- Ependymoma neuroepithelioma

- Anaplastic ependymoma germ cell tumor

- Astrocytoma germinoma

- Anaplastic astrocytoma

- Embryonal carcinoma

- Glioblastoma endodermal sinus tumor

- Gliosarcoma malignant teratoma

- Choroid plexus carcinoma

- Mixed germ cell tumor

- Cerebellar sarcoma

- Pineoblastoma

- Atypical teratoid/rhabdoid tumor

- Choriocarcinoma

- Teratoma (malignant or with malignant transformations)

- Diffusely involved brain stem tumors allowed if there is evidence of brain stem glioma
by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

- 6 months to less than 3 years

Performance Status:

- Not specified

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 2.0 mg/dL

Renal:

- Glomerular filtration rate or creatinine clearance greater than 70 mL/min

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior biologic therapy

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Prior corticosteroids allowed

Radiotherapy:

- No prior radiotherapy

Surgery:

- No more than 6 weeks since prior surgery

- Recovered from prior surgery (stable)
Minimum age
No limit
Maximum age
2 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
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 1
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
North Dakota
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oregon
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
South Dakota
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Utah
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
Canada
State/province [27] 0 0
British Columbia
Country [28] 0 0
Canada
State/province [28] 0 0
Manitoba
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Saskatchewan

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
they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation
may allow the doctors to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral
stem cell transplantation in treating infants with malignant brain or spinal cord tumors.
Trial website
https://clinicaltrials.gov/show/NCT00003141
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bruce H. Cohen, MD
Address 0 0
The Cleveland Clinic
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