CancerPhase 1/2NCT02499861
Phase I/II a Study of Decitabine in Combination With Genistein in Pediatric Relapsed or Refractory Malignancies
A Phase 1/2 study testing Decitabine and Genistein in people with Cancer, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
This Phase I/IIa study will test the combination of the epigenetic drug decitabine with the isoflavone genistein in children with leukemias and solid tumors. For the phase I study, the maximum tolerated dose will be evaluated in pediatric patients with relapsed or refractory leukemia and solid tumors. Read more about this study
- Who is it for?
- Ages 2 to 20 years
- Conditions the study is for
- Cancer
- What is being tested?
- Decitabine and Genistein
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to 24 Oct 2017
- Phase
- Phase 1/2
- 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ≥ 2 years of age and < 21 years of age at time of study enrollment
- Able to swallow genistein or take it with a puree.
- Patients must have a diagnosis of recurrent or refractory solid tumors, including Central Nervous System tumors, lymphoma or leukemia for which standard curative measures do not exist or are no longer effective
- For solid tumors, patients must have either measurable or evaluable disease. For leukemia, patients must have > 5% blasts in the bone marrow.
- Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy.
- Performance level: Karnofsky ≥50% for patients ≥ 16 years of age or Lansky ≥ 50% for patients < 16 years of age
Show all 13Show fewer
- Life expectancy at least one month
- Patients must have adequate bone-marrow function
- Patients must have normal organ as defined below: (total bilirubin ≤ 24microM/L), Amylase/pancreatic amylase≤1.5 × institutional upper limit of normal, Aspartate Aminotransferase (AST) /Alanine Aminotransferase (ALT) ≤2.5 × institutional upper limit of normal, creatinine clearance ≥60 mL/min/1.73 m2.
- OR creatinine according to age/gender
- Nervous system disorders (CTCAE v4) resulting from prior therapy must be ≤ Grade 2
- Participants of child-bearing potential and men must agree to use adequate contraception for the duration of study treatment, and 4 months after completion of decitabine and genistein administration.
- All patients and/or their parents or legally authorized representatives must sign a written informed consent
Who cannot join
- Prior decitabine or genistein therapy.
- Patients who are receiving any other investigational agents.
- Nasogastric or gastrostomy (or equivalent) administration of genistein is not allowed.
- Patients with known exclusive non-measurable leptomeningeal disease at enrolment should be excluded from this clinical trial.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to decitabine and genistein.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (receiving antibiotics), symptomatic heart or lung disease, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or breast-feeding women are excluded from this study. All girls of child bearing potential must have a negative pregnant test prior to enrolment.
- Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/IIa Study of Decitabine in Combination With Genistein in Pediatric Patients With Relapsed or Refractory Solid Tumors and Leukemia
This Phase I/IIa study will test the combination of the epigenetic drug decitabine with the isoflavone genistein in children with leukemias and solid tumors. For the phase I study, the maximum tolerated dose will be evaluated in pediatric patients with relapsed or refractory leukemia and solid tumors. For the phase II study, only patients with relapsed or refractory leukemias will be included. To further evaluate the treatment efficacy and gain further insight into action of these drugs, the DNA methylation levels before and after treatment for all participants, pharmacokinetics parameters such as through level for decitabine and through and peak level for genistein will be measured. Pharmacogenomics testing for decitabine will be performed prior to cycle 1 of treatment.
Decitabine will be administered over a 24 hours infusion on day 1 of cycle (28 days) and genistein will be taken orally twice daily from day 2 to 21, followed by a 7 days rest period.
- Conditions
- Cancer
- Being tested
- Decitabine and Genistein
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decitabine and GenisteinDrug
intravenous Decitabine with oral genistein
| Study group | Role | What they receive |
|---|---|---|
| Decitabine and Genistein | Experimental | continuous 24 hours Intravenous decitabine followed by oral genistein for 20 days. Receives: Drug: Decitabine and Genistein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of the combination of intravenous decitabine with oral genistein for children with refractory or recurrent solid malignancies and leukemia
Measured: 12-18 mnths
Number of participants with adverse events as a measurement of safety and tolerability of the combination of intravenous decitabine with oral genistein in children.
Measured: 12-18 months
Clinical benefit of the combination of intravenous decitabine with oral genistein in phase IIa of the study measure by either volumetric MRI for solid tumor or by bone marrow aspiration or biopsy for leukemia) at the end of cycle 2, 4, 6, 9 and 12.
Measured: 42 months
Secondary outcomes (3)
Plasma concentration of decitabine and genistein during cycle 1 and 2 (just in Phase I).
Measured: 12-18 months
DNA methylation levels in selected gene promoters before and after treatment.
Measured: 42 months
Quality of life assess through Peds Quality of Life Cancer module, Peds Quality of Life Fatigue module, Reported Health status 15-items, Pain Visual Analogue Scale, Distress Rating Scale, Expectations and McGill Quality of Life Questionnaire
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startJul 2015
- Primary completion24 Oct 2017
- Study completion24 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henrique Bittencourt, MD, PhD, St. Justine's Hospital
- Investigators
- Henrique Bittencourt, MD, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499861
- Sponsor's protocol ID
- DEC-GEN001
- Status last verified
- Nov 2017
- First submitted
- 10 Feb 2015
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Study of Decitabine in Combination With Genistein in Pediatric Patients With Relapsed or Refractory Solid Tumors and Leukemia
- ClinicalTrials.gov ID
- NCT02499861
- Acronym / sponsor ID
- DEC-GEN001
- Conditions
- Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 24 Oct 2017 (actual)
- Study completion
- 24 Oct 2017 (actual)
- First posted
- 16 Jul 2015 (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 Phase I/IIa study will test the combination of the epigenetic drug decitabine with the isoflavone genistein in children with leukemias and solid tumors. For the phase I study, the maximum tolerated dose will be evaluated in pediatric patients with relapsed or refractory leukemia and solid tumors. For the phase II study, only patients with relapsed or refractory leukemias will be included. To further evaluate the treatment efficacy and gain further insight into action of these drugs, the DNA methylation levels before and after treatment for all participants, pharmacokinetics parameters such as through level for decitabine and through and peak level for genistein will be measured. Pharmacogenomics testing for decitabine will be performed prior to cycle 1 of treatment.
Decitabine will be administered over a 24 hours infusion on day 1 of cycle (28 days) and genistein will be taken orally twice daily from day 2 to 21, followed by a 7 days rest period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decitabine and Genistein | Experimental | Drug: Decitabine and Genisteincontinuous 24 hours Intravenous decitabine followed by oral genistein for 20 days. |
Who may qualify
- Ages
- 2 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Age ≥ 2 years of age and < 21 years of age at time of study enrollment
- Able to swallow genistein or take it with a puree.
- Patients must have a diagnosis of recurrent or refractory solid tumors, including Central Nervous System tumors, lymphoma or leukemia for which standard curative measures do not exist or are no longer effective
- For solid tumors, patients must have either measurable or evaluable disease. For leukemia, patients must have > 5% blasts in the bone marrow.
- Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy.
Key exclusion criteria (8 listed)
- Prior decitabine or genistein therapy.
- Patients who are receiving any other investigational agents.
- Nasogastric or gastrostomy (or equivalent) administration of genistein is not allowed.
- Patients with known exclusive non-measurable leptomeningeal disease at enrolment should be excluded from this clinical trial.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to decitabine and genistein.
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 |
|---|---|---|
| Decitabine and Genisteinintravenous Decitabine with oral genistein | Drug | Decitabine and Genistein |
Primary outcome
Maximum tolerated dose of the combination of intravenous decitabine with oral genistein for children with refractory or recurrent solid malignancies and leukemia
Time frame: 12-18 mnths
Number of participants with adverse events as a measurement of safety and tolerability of the combination of intravenous decitabine with oral genistein in children.
Time frame: 12-18 months
Clinical benefit of the combination of intravenous decitabine with oral genistein in phase IIa of the study measure by either volumetric MRI for solid tumor or by bone marrow aspiration or biopsy for leukemia) at the end of cycle 2, 4, 6, 9 and 12.
Time frame: 42 months
3 secondary outcomes
Plasma concentration of decitabine and genistein during cycle 1 and 2 (just in Phase I).
Time frame: 12-18 months
DNA methylation levels in selected gene promoters before and after treatment.
Time frame: 42 months
Quality of life assess through Peds Quality of Life Cancer module, Peds Quality of Life Fatigue module, Reported Health status 15-items, Pain Visual Analogue Scale, Distress Rating Scale, Expectations and McGill Quality of Life Questionnaire
Time frame: 42 months
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 17 Nov 2017.
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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.
Henrique Bittencourt, MD principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Decitabine and Genistein in people with Cancer, run by St. Justine's Hospital at 1 site 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 13 inclusion and 8 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 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 dose of the combination of intravenous decitabine with oral genistein for children with refractory or recurrent solid malignancies and leukemia (time frame: 12-18 mnths). The study lists 3 primary outcomes in all. 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 17 Nov 2017.