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Phase I dose-finding study for melatonin in pediatric oncology patients with relapsed solid tumors
Donna L Johnston1, Susan Zupanec2, Darcy Nicksy2
1Division of Pediatric Hematology/Oncology, Children's Hospital of Eastern Ontario, Ottawa, Canada.
Background:
Melatonin is a natural health product used for sleep disturbances. In preliminary studies of adults with advanced cancer, 20 mg of melatonin daily was associated with reduction in anorexia and weight loss-symptoms that also impact pediatric oncology patients. High doses of melatonin have not been studied in pediatrics.
Methods:
This was a multicenter single-arm phase I dose-escalation study utilizing a 3 + 3 design to determine the safety and tolerability of escalating doses of melatonin in pediatric oncology patients with relapsed solid tumors. Melatonin was given for 8 weeks at three dose levels-0.075 mg/kg (maximum 5 mg), 0.15 mg/kg (maximum 10 mg), and 0.3 mg/kg (maximum 20 mg).
Results:
Melatonin was well tolerated at all three dose levels with no significant adverse events or dose-limiting toxicities. The only grade 3/4 toxicities were myelosuppression, which was attributed to the concomitant chemotherapy and occurred at all dose levels. Weight gain occurred in seven of nine patients, with a median increase of 1.1 kg (range -3.3 to 4.5) or 3.4% (range -10.2 to 8.7), with two patients losing weight (one in dose level 1 and one level 3).
Conclusions:
Melatonin is well tolerated at a dose of 0.3 mg/kg (maximum 20 mg), in the pediatric population. This study provides the background for further study of high-dose melatonin in pediatric oncology patients.
Insights
High-dose melatonin is safe for children with cancer. This study found melatonin well-tolerated in pediatric oncology patients, supporting further research into its use for managing cancer-related symptoms.
Area of Science:
- Pediatric Oncology
- Pharmacology
- Clinical Trials
Background:
- Melatonin is a natural product used for sleep disturbances.
- Preliminary adult studies suggest melatonin may reduce anorexia and weight loss in advanced cancer.
- High-dose melatonin has not been previously studied in pediatric oncology patients.
Purpose of the Study:
- To determine the safety and tolerability of escalating doses of melatonin in pediatric oncology patients with relapsed solid tumors.
- To establish a safe and effective dose range for melatonin in this population.
Main Methods:
- A multicenter, single-arm, phase I dose-escalation study.
- Melatonin was administered for 8 weeks at three dose levels: 0.075 mg/kg (max 5 mg), 0.15 mg/kg (max 10 mg), and 0.3 mg/kg (max 20 mg).
- Utilized a 3+3 design to assess safety and tolerability.
Main Results:
- Melatonin was well tolerated across all dose levels with no dose-limiting toxicities.
- The only grade 3/4 toxicities observed were myelosuppression, attributed to concurrent chemotherapy.
- Seven out of nine patients experienced weight gain, with a median increase of 3.4%.
Conclusions:
- Melatonin is well-tolerated at a dose of 0.3 mg/kg (maximum 20 mg) in pediatric oncology patients.
- This study supports further investigation of high-dose melatonin for managing symptoms in pediatric cancer patients.
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