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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/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
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Scientific title
A Phase II Study of Irinotecan + Temozolomide in Children With Recurrent Neuroblastoma
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Secondary ID [1]
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CDR0000465487
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Secondary ID [2]
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ANBL0421
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neuroblastoma
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Condition category
Condition code
Cancer
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Neuroendocrine tumour (NET)
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Cancer
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Children's - Other
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Response - Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)
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Assessment method [1]
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The patient's best overall response obtained during Reporting Periods 1 and 2 will be scored as "best response". Patients enrolled on Stratum 1 with bone marrow disease, a responder has no tumor cells detectable by routine morphology on 2 subsequent bilateral bone marrow aspirates and biopsies done at least 3 weeks apart. For patients enrolled on stratum 1 with MIBG only disease, response will be assessed using the Curie scale. Patients who have complete resolution of all MIBG positive lesions (CR) or resolution of at least one MIBG positive lesion with persistence of other lesions (PR) will be considered responders. For Stratum 2 a responder is defined to be a patient who achieves a best overall response of CR, VGPR or PR from CT/MRI scans from central review using (RECIST) Response Evaluation Criteria in Solid Tumor. A responder is defined to be a patient who achieves a best overall response of CR (Complete Response), VGPR (Very Good Partial Response) or PR (Partial Response).
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Timepoint [1]
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up to 6 courses of therapy, or about 6 months
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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
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Minimum age
No limit
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Maximum age
21
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
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Actual
1/12/2013
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Sample size
Target
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Accrual to date
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Final
59
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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John Hunter Hospital - Newcastle
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Westmead Institute for Cancer Research at Westmead Hospital - Westmead
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Royal Children's Hospital - Brisbane
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Royal Children's Hospital - Parkville
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Princess Margaret Hospital for Children - Perth
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2310 - Newcastle
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2145 - Westmead
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4029 - Brisbane
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3052 - Parkville
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6001 - Perth
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
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Name
Children's Oncology Group
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Address
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National Cancer Institute (NCI)
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Summary
Brief summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving irinotecan together with
temozolomide works in treating young patients with recurrent neuroblastoma.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00311584
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Trial related presentations / publications
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Contacts
Principal investigator
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Rochelle Bagatell, MD
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Address
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University of Arizona
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00311584
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