Relapsed Malignant Solid TumorPhase 1NCT01858155
Phase I Dose Finding Study for Melatonin in Pediatric Oncology Patients With Relapsed Solid Tumors
A Phase 1 study testing Melatonin in people with Relapsed Malignant Solid Tumor, run by C17 Council at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Relapsed Malignant Solid Tumor
- What is being tested?
- Melatonin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 5 sitesCanada
- Study dates
- May 2013to 31 Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
CHU Ste-Justine
Montreal, Quebec, H3T 1C5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Children's & Women's Health Centre of British Columbia
Vancouver, British Columbia, V6H 3V4
About this study
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
- Being tested
- Melatonin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Also called SISU Melatonin
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | Not described Receives: Drug: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated daily dose of melatonin.
Measured: 8 Weeks
Secondary outcomes (4)
Number of dose limiting toxicities during 8 weeks of melatonin therapy.
Measured: 8 Weeks
Peak plasma concentration (Cmax) and area under the plasma concentration versus time curve (AUC) of Melatonin.
Measured: 8 Weeks
The quantity of cytokines will be measured during 8 weeks of melatonin therapy.
Measured: 8 Weeks
Change from Baseline in weight after 8 weeks of therapy.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Malignant Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- C17 Council
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donna Johnston, MD, Principal investigator, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858155
- Sponsor's protocol ID
- C17 MEL P1
- Status last verified
- Jan 2019
- First submitted
- 15 May 2013
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Finding Study for Melatonin in Pediatric Oncology Patients With Relapsed Solid Tumors
- ClinicalTrials.gov ID
- NCT01858155
- Acronym / sponsor ID
- C17 MEL P1
- Conditions
- Relapsed Malignant Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- C17 CouncilUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 21 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Experimental | Drug: Melatonin |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninAlso: SISU Melatonin | Drug | Melatonin |
Primary outcome
Maximum tolerated daily dose of melatonin.
Time frame: 8 Weeks
4 secondary outcomes
Number of dose limiting toxicities during 8 weeks of melatonin therapy.
Time frame: 8 Weeks
Peak plasma concentration (Cmax) and area under the plasma concentration versus time curve (AUC) of Melatonin.
Time frame: 8 Weeks
The quantity of cytokines will be measured during 8 weeks of melatonin therapy.
Time frame: 8 Weeks
Change from Baseline in weight after 8 weeks of therapy.
Time frame: 8 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
Related trials for Relapsed Malignant Solid Tumor
Active, not recruitingPhase 2
Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 1/2
A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01)
Malignant Neoplasm
Active, not recruitingPhase 2
Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Recurrent Childhood Ependymoma
Not yet recruiting
Umbilical Cord Blood Infusion to Promote Hematopoietic and Immune Reconstitution in Children With Relapsed or Refractory Malignant Solid Tumors
Pediatric Cancer, Solid Tumor Cancer
RecruitingPhase 1/2
A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)
Malignant Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna Johnston, MD principal investigator
Children's Hospital of Eastern Ontario
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Melatonin in people with Relapsed Malignant Solid Tumor, run by C17 Council at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated daily dose of melatonin. (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.