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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/NCT00025558




Registration number
NCT00025558
Ethics application status
Date submitted
11/10/2001
Date registered
27/01/2003
Date last updated
28/03/2011

Titles & IDs
Public title
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Brain Cancer
Scientific title
Dose Escalation of Temozolomide in Combination With Thiotepa and Carboplatin With Autologous Stem Cell Rescue in Patients With Malignant Brain Tumors With Minimal Residual Disease
Secondary ID [1] 0 0
P30CA016087
Secondary ID [2] 0 0
CDR0000068973
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain and Central Nervous System Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Brain
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 - temozolomide
Treatment: Drugs - thiotepa
Treatment: Surgery - autologous bone marrow transplantation
Treatment: Surgery - peripheral blood stem cell transplantation

Other interventions: filgrastim


Treatment: Drugs: carboplatin


Treatment: Drugs: temozolomide


Treatment: Drugs: thiotepa


Treatment: Surgery: autologous bone marrow transplantation


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

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Diagnosis of one of the following malignant brain tumors:

- Anaplastic astrocytoma

- Glioblastoma multiforme

- Anaplastic oligodendroglioma

- Medulloblastoma

- High-grade ependymoma

- Germ cell tumors

- Pineoblastoma

- Other primitive neuroectodermal tumors

- Recurrent disease or resistant to conventional therapy (e.g., surgery, radiotherapy,
or standard chemotherapy)

- No prior myeloablative doses of thiotepa OR

- Newly diagnosed malignant glioma with minimal residual disease after prior
radiotherapy

- Minimal residual disease is defined as tumor with maximum diameter of less than
1.5 cm by MRI and no corticosteroid dependency

PATIENT CHARACTERISTICS:

Age:

- Over 1 to under 50

Performance status:

- Karnofsky 70-100% OR

- Lansky 70-100%

Life expectancy:

- More than 12 weeks

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm3

- Platelet count at least 100,000/mm3

- Hemoglobin at least 10 g/dL (transfusion allowed)

Hepatic:

- Bilirubin less than 1.5 times upper limit of normal (ULN)

- SGOT/SGPT less than 2.5 times ULN

- Alkaline phosphatase less than 2.5 times ULN

Renal:

- Creatinine less than 1.5 times ULN

- Creatinine clearance at least 70 mL/min

- BUN less than 1.5 times ULN

Cardiovascular:

- Ejection fraction greater than 50% OR

- Shortening fraction greater than 27%

- No evidence of myocardial ischemia on EKG if over 40 years of age

Other:

- HIV negative

- No AIDS-related illness

- No frequent vomiting or medical condition that would preclude oral medication (e.g.,
partial bowel obstruction)

- No other malignancy within the past 2 years except surgically cured carcinoma in situ
of the cervix or basal cell or squamous cell skin cancer

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 2 weeks since prior biologic therapy or immunotherapy

Chemotherapy:

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
recovered

Endocrine therapy:

- See Disease Characteristics

Radiotherapy:

- See Disease Characteristics

- At least 6 weeks since prior radiotherapy and recovered

- At least 6 weeks since prior brachytherapy or radiosurgery

Surgery:

- See Disease Characteristics

- Recovered from prior major surgery
Minimum age
1 Year
Maximum age
49 Years
Sex
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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
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
1/10/2000
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
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
Ohio
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania

Funding & Sponsors
Primary sponsor type
Other
Name
NYU Langone Health
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. Peripheral stem cell transplantation or bone marrow transplantation
may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining temozolomide, thiotepa, and
carboplatin followed by peripheral stem cell transplantation or bone marrow transplantation
in treating patients who have brain cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00025558
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sharon L. Gardner, MD
Address 0 0
NYU Langone Health
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/NCT00025558