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

NCT01858155 | Completed Phase 1 DMC

• 1 other identifier: C17 MEL P1
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 5

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.

Conditions

Relapsed Malignant Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated daily dose of melatonin.

  8 Weeks

Secondary Outcomes (4)

• Number of dose limiting toxicities during 8 weeks of melatonin therapy.

  8 Weeks

• Peak plasma concentration (Cmax) and area under the plasma concentration versus time curve (AUC) of Melatonin.

  8 Weeks

• The quantity of cytokines will be measured during 8 weeks of melatonin therapy.

  8 Weeks

• Change from Baseline in weight after 8 weeks of therapy.

  8 Weeks

Study Arms (1)

Melatonin

EXPERIMENTAL

Drug: Melatonin

Interventions

Melatonin DRUG

Also known as: SISU Melatonin

Melatonin

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• C17 Council: lead

Study Sites (5)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Children's & Women's Health Centre of British Columbia

Vancouver, British Columbia, V6H 3V4, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

CHU Ste-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Donna Johnston, MD

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: May 21, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 31, 2017
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

CA (5)