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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00311584




Registration number
NCT00311584
Ethics application status
Date submitted
5/04/2006
Date registered
6/04/2006
Date last updated
30/09/2014

Titles & IDs
Public title
Irinotecan and Temozolomide in Treating Young Patients With Recurrent Neuroblastoma
Scientific title
A Phase II Study of Irinotecan + Temozolomide in Children With Recurrent Neuroblastoma
Secondary ID [1] 0 0
CDR0000465487
Secondary ID [2] 0 0
ANBL0421
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuroblastoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Children's - Other

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - irinotecan hydrochloride
Treatment: Drugs - temozolomide

Experimental: Disease measurable by CT or MRI scan (Irinotecan/Temozolomide) - Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride IV (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Experimental: Disease eval by bone marrow or MIBG (Irinotecan/Temozolomide) - Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride IV (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.


Treatment: Drugs: irinotecan hydrochloride
Given IV

Treatment: Drugs: temozolomide
Given IV
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response - Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)
Timepoint [1] 0 0
up to 6 courses of therapy, or about 6 months

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Histologically confirmed neuroblastoma AND/OR demonstration of tumor cells in the bone marrow with increased urinary catecholamines at initial diagnosis

* Patients with elevated catecholamines only are not eligible
* Meets 1 of the following criteria:

* Recurrent disease following aggressive, multidrug, frontline chemotherapy, defined as chemotherapy given with = 2 agents, including an alkylating agent and a platinum-containing compound
* Resistant/refractory disease during aggressive, multidrug, frontline chemotherapy
* Must meet 1 of the following criteria for documentation of disease:

* Unidimensionally measurable tumor = 20 mm by MRI (Magnetic Resonance Imaging), CT scan (Computed Tomography), or x-ray OR = 10 mm by spiral CT scan within 4 weeks prior to study entry

* Patients with residual stable tumor upon completion of frontline therapy must undergo biopsy to document presence of a viable neuroblastoma
* If the measurable target lesion was previously radiated, a biopsy must be performed = 4 weeks after radiation was completed AND the biopsy must demonstrate viable neuroblastoma
* MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical) with positive uptake at = 1 site within 4 weeks prior to study entry

* Patients with residual stable MIBG-positive lesions upon completion of frontline therapy must undergo biopsy to document presence of viable neuroblastoma
* If the patient has only 1 MIBG-positive lesion, and that lesion was previously radiated, a biopsy must be performed = 4 weeks after radiation was completed AND the biopsy must demonstrate viable neuroblastoma
* Bone marrow with tumor cells on routine morphology (not by neuron-specific enolase staining only) of bilateral aspirate and/or biopsy on 1 bone marrow sample within 2 weeks prior to study entry
* No extensive marrow disease
* No myelodysplastic syndrome

PATIENT CHARACTERISTICS:

* Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) OR Lansky PS 50-100% (for patients = 16 years of age)
* Life expectancy = 8 weeks
* Absolute neutrophil count = 750/mm^3
* Platelet count = 75,000/mm^3 (transfusion independent)
* Hemoglobin = 8.5 mg/dL (transfusion allowed)
* Creatinine adjusted according to age as follows:

* No greater than 0.4 mg/dL (= 5 months)
* No greater than 0.5 mg/dL (6 months -11 months)
* No greater than 0.6 mg/dL (1 year-23 months)
* No greater than 0.8 mg/dL (2 years-5 years)
* No greater than 1.0 mg/dL (6 years-9 years)
* No greater than 1.2 mg/dL (10 years-12 years)
* No greater than 1.4 mg/dL (13 years and over [female])
* No greater than 1.5 mg/dL (13 years to 15 years [male])
* No greater than 1.7 mg/dL (16 years and over [male]) OR
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
* Bilirubin = 1.5 times upper limit of normal (ULN) for age
* ALT < 2.5 times ULN for age
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Seizure disorder allowed provided seizures are well controlled on non-EIAC medication
* No active diarrhea or uncontrolled infection
* No other malignancy, including secondary malignancy

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Prior front-line therapy (e.g., surgery, chemotherapy, immunotherapy, radiotherapy, or retinoids) allowed
* Recovered from prior therapy
* More than 4 weeks since prior radiation therapy to the site of any lesion that will be identified as a target lesion to measure tumor response
* At least 2 weeks since prior myelosuppressive therapy (4 weeks for nitrosourea)
* At least 1 week since prior therapy with an antineoplastic biologic agent or retinoid
* At least 1 week since prior growth factors
* At least 1 week since prior and no other concurrent anticancer agents
* At least 1 week since prior and no concurrent enzyme-inducing anticonvulsants (EIAC), including phenytoin, phenobarbital, valproic acid, or carbamazepine

* Concurrent gabapentin or levetiracetam allowed
* Concurrent palliative radiation therapy to sites not used to measure tumor response allowed
* No prior allogeneic stem cell transplantation (SCT)

* Prior autologous SCT allowed
* No prior second-line chemotherapy for relapsed or refractory disease
* No concurrent immunomodulating agents

* Concurrent steroids for transfusion/infusion reactions or for treatment of edema associated with CNS lesions allowed
Minimum age
No limit
Maximum age
21 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
Parallel
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
1/04/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
59
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [2] 0 0
Westmead Institute for Cancer Research at Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Royal Children's Hospital - Brisbane
Recruitment hospital [4] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [5] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2310 - Newcastle
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
3052 - Parkville
Recruitment postcode(s) [5] 0 0
6001 - Perth
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
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Arkansas
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California
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Colorado
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Connecticut
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Delaware
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District of Columbia
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Florida
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Georgia
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Hawaii
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Idaho
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Illinois
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Indiana
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Iowa
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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Nevada
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Vermont
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Virginia
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Washington
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West Virginia
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United States of America
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Wisconsin
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
State/province [46] 0 0
Quebec
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Canada
State/province [47] 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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rochelle Bagatell, MD
Address 0 0
University of Arizona
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Bagatell R, London WB, Wagner LM, Voss SD, Stewart... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00311584