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Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuroblastoma

Intervention: isotretinoin (Drug); DNA analysis (Genetic); polymerase chain reaction (Genetic); laboratory biomarker analysis (Other); pharmacological study (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Children's Cancer and Leukaemia Group

Official(s) and/or principal investigator(s):
Gareth Veal, Principal Investigator, Affiliation: University of Newcastle Upon-Tyne

Summary

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.

Clinical Details

Official title: Pilot Study to Investigate the Feasibility of 13-cis-retinoic Acid Pharmacokinetic Monitoring in High-risk Neuroblastoma Patients

Study design: Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Pharmacokinetics of isotretinoin

Toxicity according to NCI CTCAE v.3

Secondary outcome: Clinical response

Detailed description: 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

Minimum age: N/A. Maximum age: 18 Years. Gender(s): Both.

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

Locations and Contacts

Great Ormond Street Hospital for Children, London, England WC1N 3JH, United Kingdom; Recruiting
Penelope Brock, MD, PhD, Phone: 44-20-7829-7924, Email: Brockp@gosh.nhs.uk

University of Newcastle-Upon-Tyne Northern Institute for Cancer Research, Newcastle-Upon-Tyne, England NE2 4HH, United Kingdom; Recruiting
Gareth Veal, Phone: 44-191-246-4332

Royal Marsden - Surrey, Sutton, England SM2 5PT, United Kingdom; Recruiting
Andrew David J. Pearson, MD, FRCP, DCh, Phone: 44-208-661-3163

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: February 2009
Last updated: August 9, 2013

Page last updated: August 23, 2015

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