Relapsed Malignant Solid Tumor Clinical Trial
Official title:
Phase I Dose Finding Study for Melatonin in Pediatric Oncology Patients With Relapsed Solid Tumors
| Verified date | January 2019 |
| Source | C17 Council |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 daily, as well as to determine the maximum tolerated dose of melatonin.
| Status | Completed |
| Enrollment | 9 |
| Est. completion date | December 31, 2017 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years to 18 Years |
| Eligibility |
Inclusion Criteria: - 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: 1. 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) 2. 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 Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Alberta Children's Hospital | Calgary | Alberta |
| Canada | CHU Ste-Justine | Montreal | Quebec |
| Canada | Children's Hospital of Eastern Ontario | Ottawa | Ontario |
| Canada | The Hospital for Sick Children | Toronto | Ontario |
| Canada | Children's & Women's Health Centre of British Columbia | Vancouver | British Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| C17 Council |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum tolerated daily dose of melatonin. | 8 Weeks | ||
| Secondary | Number of dose limiting toxicities during 8 weeks of melatonin therapy. | 8 Weeks | ||
| Secondary | Peak plasma concentration (Cmax) and area under the plasma concentration versus time curve (AUC) of Melatonin. | 8 Weeks | ||
| Secondary | The quantity of cytokines will be measured during 8 weeks of melatonin therapy. | 8 Weeks | ||
| Secondary | Change from Baseline in weight after 8 weeks of therapy. | 8 Weeks |