Status:
COMPLETED
Phase I Dose Finding Study for Melatonin in Pediatric Oncology Patients With Relapsed Solid Tumors
Lead Sponsor:
C17 Council
Conditions:
Relapsed Malignant Solid Tumor
Eligibility:
All Genders
2-18 years
Phase:
PHASE1
Brief Summary
This study will evaluate dose escalation of melatonin in pediatric oncology patients with relapsed solid tumors. The purpose of this study is to determine the safety of melatonin at a dose up to 20 mg...
Eligibility Criteria
Inclusion
- Patients must be able to take medication by mouth either by swallowing, chewing or sublingual routes.
- Patients must have a documented life expectancy of ≥ 8 weeks.
- Patients must have histologic or radiographic evidence of a relapsed malignant solid tumor. Intrinsic brain stem tumors or optic pathway gliomas may be diagnosed by clinical and radiologic methods.
- Patient, parent, legal representative and/or guardian must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
- Minimum Weight Requirements: Dose level 1 - 22.2kg, Dose level 2 - 11.1kg, Dose level 3 - 5.6kg
- Patients must be taking a stable dose (with no additions, modifications or deletions) of chemotherapy started ≥ 14 days prior study enrollment.
- Prescribed Chemotherapy drug(s) must not be known to interact with melatonin
- Adequate Bone Marrow Function Defined as:
- Patients with solid tumors without bone marrow involvement:
- Peripheral absolute neutrophil count (ANC) ≥ 1 x109/L
- Platelet count ≥ 50 X 109/L (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment)
- Hemoglobin ≥ 80 g/L (may receive RBC transfusions)
- Patients with known bone marrow metastatic disease are eligible for study but not evaluable for hematologic toxicity.
- Must not be known to be refractory to red cell or platelet transfusions.
- These patients do not need to meet the bone marrow function requirements, as hematological toxicity will not be measured due to metastatic disease.
- Adequate Liver Function Defined as:
- Total Bilirubin ≤ 1.5 x upper limit of normal (ULN) for age.
- ALT ≤ 1.5 x ULN for age.
Exclusion
- Chemotherapy: Melatonin inhibits the action of doxorubicin
- Growth factors that support white cell number administered ≤ 7 days prior to enrollment.
- Patients requiring corticosteroids who are not on a stable or decreasing dose of corticosteroid for ≥ 14 days.
- Patients prescribed immunosuppressant therapy that is not specifically utilized for chemotherapy purposes. Patient prescribed: Cyclosporine, Mycophenolate Mofetil HCL, Tacrolimus, Sirolimus and Azathioprine should be excluded
- Patients prescribed anti-coagulation therapy (Warfarin, Low Molecular Weight Heparin (LMWH), or System Heparin Therapy)
- Concomitant medications that are known CYP1A2 inhibitors interact with Melatonin.
- Patients prescribed megace, corticosteroids and periactin started ≤ 14 days prior to study enrollment.
- Patients taking the following medications: benzodiazepines, nifedipine, NSAID's, ASA and/or Beta Blockers
- Patients ≤ 7 days post-operative from any surgical procedure.
- Patients with any signs of active post-operative bleeding.
- Patients with an infection that is not responding to anti-microbial therapy.
- Any condition that would negatively impact effective gut absorption and/or swallowing of study medication.
- Patients in the opinion of the investigator may not be able to comply with study protocol requirements
- Patients already receiving melatonin are excluded from the study.
- Allergies to the medicinal and/or non-medicinal ingredients of melatonin which include: Melatonin, Calcium Salicate, Croscarmellose Sodium, IsoMalt, Magnesium Stearate, Microcrystalline Cellulose.
- As melatonin can cause fatigue, patients taking melatonin should refrain from driving or operating machinery within 5 hours of taking the melatonin.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01858155
Start Date
May 1 2013
End Date
December 31 2017
Last Update
January 31 2019
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
2
Children's & Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada, V6H 3V4
3
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
4
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8