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The purpose of this study is to determine the best dose of imetelstat when given alone for patients with neuroblastoma and also when given in combination with 13-cis-retinoic acid.
Full description
This research is being done because imetelstat has been shown to slow the growth of tumours in animals and may also be doing so in adults, but we are not sure if it can also slow tumour growth in children and offer better results than standard treatment. Laboratory studies suggest imetelstat may increase the activity of 13-cis-retinoic acid, which is used to treat neuroblastoma, although this is not yet proven in patients.
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Inclusion criteria
Histological verification of neuroblastoma at either original diagnosis or relapse.
Patients must have recurrent or refractory neuroblastoma with either measurable or evaluable disease (defined by a positive nuclear scan such as bone scan or metaiodobenzylguanidine (MIBG) scan). If a lesion is isolated and /or previously irradiated and stable, a proven positive biopsy will be required to be eligible.
Current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.
Must have recovered from the acute effects of prior chemotherapy, immunotherapy or radiotherapy prior to study entry as follows:
Age >18 months and ≤18 years at the time of study entry.
Performance Status:
Patients ≤10 years: Lansky ≥50 Patients >10 years: Karnofsky ≥60% - Laboratory Requirements: (must be done within 7 days prior to registration)
Adequate Bone Marrow Function, defined as:
Patients will be eligible as long as blood count criteria are met. If patients then experience prolonged myelosuppression, bone marrow examination can be requested to determine if the low blood counts are due to malignant infiltration of the marrow or to therapy induced hypoplasia/aplasia.
Adequate Renal And Cardiac Function, defined as:
Adequate Liver Function, defined as:
Adequate Coagulation Function, defined as:
• PTT <1.2 x upper limit normal
Exclusion criteria
Patients with >25% bone marrow involvement will not be enrolled.
Patients must be able to take oral medication and have no gastrointestinal abnormalities (e.g. bowel obstruction or previous gastric resection) which would lead to inadequate absorption of 13-cisretinoic acid.
Known HIV, hepatitis B or hepatitis C infections.
Imetelstat animal and in vitro studies suggest it is not genotoxic or teratogenic. However, 13-cis-retinoic acid is known to be teratogenic. Pregnancy tests must be obtained in girls who are post menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two reliable contraceptive methods. Pregnant or breast-feeding females will not be entered on this study due to the potential fetal and teratogenic adverse effects.
Concurrent Medications:
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0 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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