Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Children's Cancer and Leukaemia Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00939965
First received: July 14, 2009
Last updated: July 23, 2009
Last verified: July 2009
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Purpose
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors plan better treatment for patients receiving isotretinoin.
PURPOSE: This clinical trial is studying the side effects and best dose of isotretinoin in treating young patients with high-risk neuroblastoma.
| Condition | Intervention |
|---|---|
|
Neuroblastoma |
Drug: isotretinoin Genetic: DNA analysis Genetic: polymerase chain reaction Other: laboratory biomarker analysis Other: pharmacological study |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study to Investigate the Feasibility of 13-cis-retinoic Acid Pharmacokinetic Monitoring in High-risk Neuroblastoma Patients |
Resource links provided by NLM:
Genetics Home Reference related topics:
neuroblastoma
Drug Information available for:
Isotretinoin
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Pharmacokinetics of isotretinoin [ Designated as safety issue: No ]
- Toxicity according to NCI CTCAE v.3 [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Clinical response [ Designated as safety issue: No ]
| Estimated Enrollment: | 75 |
| Study Start Date: | February 2009 |
OBJECTIVES:
Primary
- To investigate the feasibility of implementing individualized dosing of isotretinoin in patients with high-risk neuroblastoma after course 1 of treatment, based on isotretinoin pharmacokinetics and toxicity.
- To minimize the large inter-patient variation in plasma concentrations of isotretinoin.
- To ensure that patients are not exposed to potentially sub-optimal plasma concentrations of isotretinoin during long-term treatment, particularly for patients who are not able to swallow isotretinoin capsules.
Secondary
- To obtain preliminary data on the potential impact of isotretinoin therapeutic monitoring on clinical response and toxicity in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral isotretinoin twice daily on days 1-14. Courses repeat every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and during courses 1-3 for pharmacokinetic studies and determination of each patient's individual therapeutic-dose level requirement. Genotyping to identify genes that metabolize enzymes is conducted via PCR.
After completion of study therapy, patients are followed up periodically for up to 3 years.
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed high-risk neuroblastoma
- Concurrent isotretinoin as part of clinical treatment
PATIENT CHARACTERISTICS:
- Not pregnant
- Fertile patients must use effective contraception
- Has a single- or double-lumen central venous catheter in place
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00939965
Locations
| United Kingdom | |
| Great Ormond Street Hospital for Children | Recruiting |
| London, England, United Kingdom, WC1N 3JH | |
| Contact: Penelope Brock, MD, PhD 44-20-7829-7924 Brockp@gosh.nhs.uk | |
| University of Newcastle-Upon-Tyne Northern Institute for Cancer Research | Recruiting |
| Newcastle-Upon-Tyne, England, United Kingdom, NE2 4HH | |
| Contact: Gareth Veal 44-191-246-4332 | |
| Royal Marsden - Surrey | Recruiting |
| Sutton, England, United Kingdom, SM2 5PT | |
| Contact: Andrew David J. Pearson, MD, FRCP, DCh 44-208-661-3163 | |
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
| Principal Investigator: | Gareth Veal | University of Newcastle Upon-Tyne |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00939965 History of Changes |
| Other Study ID Numbers: | CDR0000637053, CCLG-PK-2008-03, EU-20914, EUDRACT-2008-003606-33 |
| Study First Received: | July 14, 2009 |
| Last Updated: | July 23, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
localized unresectable neuroblastoma recurrent neuroblastoma stage 4S neuroblastoma |
Additional relevant MeSH terms:
|
Neuroblastoma Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Isotretinoin Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013