Phase I Dose Finding Study for Melatonin in Pediatric Oncology Patients With Relapsed Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01858155
Recruitment Status : Recruiting
First Posted : May 21, 2013
Last Update Posted : January 31, 2017
Information provided by (Responsible Party):
C17 Council

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 daily, as well as to determine the maximum tolerated dose of melatonin.

Condition or disease Intervention/treatment Phase
Relapsed Malignant Solid Tumor Drug: Melatonin Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Phase I Dose Finding Study for Melatonin in Pediatric Oncology Patients With Relapsed Solid Tumors
Study Start Date : May 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Melatonin Drug: Melatonin
Other Name: SISU Melatonin

Primary Outcome Measures :
  1. Maximum tolerated daily dose of melatonin. [ Time Frame: 8 Weeks ]

Secondary Outcome Measures :
  1. Number of dose limiting toxicities during 8 weeks of melatonin therapy. [ Time Frame: 8 Weeks ]
  2. Peak plasma concentration (Cmax) and area under the plasma concentration versus time curve (AUC) of Melatonin. [ Time Frame: 8 Weeks ]
  3. The quantity of cytokines will be measured during 8 weeks of melatonin therapy. [ Time Frame: 8 Weeks ]
  4. Change from Baseline in weight after 8 weeks of therapy. [ Time Frame: 8 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01858155

Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Victor Lewis, MD    403-955-7237   
Principal Investigator: Victor Lewis, MD         
Canada, British Columbia
Children's & Women's Health Centre of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Rod Rassekh, MD    604-875-2644   
Principal Investigator: Rod Rassekh, MD         
Canada, Ontario
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Donna Johnston, MD    613-737-7600 ext 2751   
Principal Investigator: Donna Johnston, MD         
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Sylvain Baruchel, MD    416-813-7795   
Principal Investigator: Sylvain Baruchel, MD         
Canada, Quebec
CHU Ste-Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Yvan Samson, MD    514-345-4969   
Principal Investigator: Yvan Samson, MD         
Sponsors and Collaborators
C17 Council
Principal Investigator: Donna Johnston, MD Children's Hospital of Eastern Ontario

Responsible Party: C17 Council Identifier: NCT01858155     History of Changes
Other Study ID Numbers: C17 MEL P1
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants