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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000637053 | Registry Identifier | PDQ (Physician Data Query) | |
| EU-20914 | |||
| EUDRACT-2008-003606-33 |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| isotretinoin | Drug | |||
| DNA analysis | Genetic | |||
| polymerase chain reaction | Genetic | |||
| laboratory biomarker analysis | Other | |||
| pharmacological study | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of isotretinoin | ||
| Toxicity according to NCI CTCAE v.3 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Gareth Veal | University of Newcastle Upon-Tyne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Great Ormond Street Hospital for Children | Recruiting | London | England | WC1N 3JH | United Kingdom |
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| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D015474 | Isotretinoin |
| D016133 | Polymerase Chain Reaction |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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| University of Newcastle-Upon-Tyne Northern Institute for Cancer Research | Recruiting | Newcastle upon Tyne | England | NE2 4HH | United Kingdom |
|
| Royal Marsden - Surrey | Recruiting | Sutton | England | SM2 5PT | United Kingdom |
|
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |