LymphomaPhase 2UVA-Gen001NCT02624388
Study of Genistein in Pediatric Oncology Patients (UVA-Gen001)
A Phase 2 study testing Genistein in people with Lymphoma and Childhood Lymphoma, run by University of Virginia at 1 site in United States.
Trial summary
Toxicities related to pediatric cancer treatment can lead to significant illness, organ damage, treatment delays, increased health care cost, and decrease in quality of life. Such toxicities are largely due to tissue damage sustained by chemotherapy, and strategies designed to limit such cellular damage to normal… Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Lymphoma, Childhood Lymphoma, Solid Tumor
- What is being tested?
- Genistein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Sep 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Newly diagnosed solid tumor or lymphoma with histological verification
- Age 1 - 21 years at time of diagnosis
- Karnofsky/Lanksy performance score of ≥ 50
- Able to tolerate enteral medication administration
- Planned chemotherapeutic regimen for a patient must meet all of the following criteria:
- A known myelosuppressive regimen which includes at least two of the following agents: actinomycin, carboplatin, cisplatin, cyclophosphamide, daunorubicin, doxorubicin, etoposide, ifosfamide, topotecan
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- At least four consecutive cycles
- Cycle length is either 14 or 21 days
- Regimen must either alternate myelosuppressive chemotherapeutic agents in an X-Y-X-Y format, such that the same chemotherapy is given every other cycle (e.g. vincristine/doxorubicin/cyclophosphamide │ ifosfamide/etoposide), or repeat the same chemotherapeutic agents each cycle in an X-X-X-X format (e.g. repeated cycles of cisplatin/etoposide/bleomycin). Courses eligible for this trial may occur at any time during treatment provided that they are consecutive and follow the one of the described patterns. Non-myelosuppressive anti-neoplastic treatments will not be considered for the purposes of determining eligibility. Questions regarding whether or not a patient's chemotherapy plan meets inclusion criteria will be decided by the Study Chair.
- Informed consent or parental permission and assent obtained prior to trial-related activities
- Able and willing to comply with all study related procedures
- Women of childbearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Who cannot join
- Known allergy to soy or any soy-based food or supplement
- Unable or unwilling to discontinue consuming prohibited soy-based food or supplements while participating in this study
- Pre-existing neutropenia or neutrophil qualitative or quantitative disorder
- Pre-existing cytopenia or bone marrow failure syndrome
- History of gastric or duodenal ulcers or hyperacidity syndromes
- History of Human Immunodeficiency Virus (HIV)
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- Has an active infection requiring systemic therapy
- Planned treatment does not include myelosuppressive chemotherapy
- Enrolled on a therapeutic or supportive care clinical trial within the last 30 days
- Current acute or chronic leukemia diagnosis
- Requires medication dosing via an enteral feeding tube that terminates in the duodenum or jejunum. (Enteral feeding tubes that terminate in the stomach are acceptable for study medication delivery.)
- Pregnant or breastfeeding woman
- Incarceration
- Secondary malignancy, i.e. the cancer for which the patient is presently or will be receiving treatment may not be a malignancy related to prior cancer therapy
- Any condition which might be worsened by estrogen, such as breast cancer, uterine cancer, ovarian cancer, endometriosis or uterine fibroids
- Any condition, in the investigator's opinion, that would compromise patient safety or study outcomes
- Anyone who, in the investigator's discretion, would be unwilling or unable to comply with study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: A Randomized, Placebo-Controlled Pilot Study of Genistein Supplementation in Pediatric Cancer Patients Receiving Myelosuppressive Chemotherapy
Toxicities related to pediatric cancer treatment can lead to significant illness, organ damage, treatment delays, increased health care cost, and decrease in quality of life. Such toxicities are largely due to tissue damage sustained by chemotherapy, and strategies designed to limit such cellular damage to normal tissues may reduce therapy-related morbidity and mortality. In addition to their in vitro and in vivo anti-cancer effects, naturally occurring soy isoflavones have anti-inflammatory and anti-oxidant properties, and have been shown to reduce side effects of therapy in adult oncology clinical trials. This study will examine the effect of genistein, the major isoflavone component in soybeans and the most extensively studied of the soy isoflavones, on short-term side effects of myelosuppressive chemotherapy in pediatric cancer patients. Subjects will be randomized to receive either: a) 30 mg genistein daily throughout chemotherapy Cycles 1 and 2 and placebo during chemotherapy Cycles 3 and 4; or b) placebo daily during chemotherapy Cycles 1 and 2 and 30 mg genistein daily during chemotherapy Cycles 3 and 4. Investigators hypothesize that subjects will have fewer short-term therapy-related side effects during cycles of chemotherapy given in conjunction with genistein supplementation than cycles given with placebo.
Read the detailed description
This is a multi-center, randomized, double blind, placebo-controlled crossover study to evaluate the effect of soy isoflavones on the short term untoward effects of myelosuppressive chemotherapy used to treat pediatric cancers. Newly diagnosed cancer patients aged 1-21 years will be registered to the study and informed consent will be obtained prior to any study-related procedures. Stratification will be based on length of chemotherapy cycles, between 14 day and 21 day cycles. Within strata registered subjects will be randomized 1:1 to one of two schedules:
Arm A: Subjects will receive genistein daily throughout chemotherapy cycles 1 and 2, and placebo during chemotherapy cycles 3 and 4
Arm B: Subjects will receive placebo daily throughout chemotherapy cycles 1 and 2, and genistein during chemotherapy cycles 3 and 4
Subjects will be assessed for safety and efficacy during each cycle with clinical labs, cytokine panels, and physical exams. Drug compliance will be monitored by use of a patient diary as well as monitoring of serum genistein levels. Adverse events will be monitored starting on Cycle 1 Day 1 through 30 days following the last day of protocol therapy (genistein/placebo).
- Conditions
- Lymphoma, Childhood Lymphoma, Solid Tumor, Childhood Solid Tumor, Neuroblastoma, Ewing Sarcoma
- Being tested
- Genistein, Placebo
- Keywords
- Genistein, Soy, Chemotherapy side-effects, Pediatric Cancer, Isoflavone
- Medical subject headings
- Lymphoma, Neuroblastoma, Sarcoma, Ewing, Hodgkin Disease, Lymphoma, Non-Hodgkin, Rhabdomyosarcoma, Sarcoma, Medulloblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenisteinDrug
Also called 5, 7-dihydroxy-3-(4-hydroxyphenyl)-4H-1-benzopyran-4-one, i-cool tablets containing 30 mg geniVida™
Estrogen-like compound (isoflavone) derived from soybeans
PlaceboDrug
Pill that contains no medicine
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Genistein followed by Placebo | Experimental | Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4 Receives: Drug: Genistein; Drug: Placebo |
| Arm B: Placebo followed by Genistein | Experimental | Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4 Receives: Drug: Genistein; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Neutrophil Count Recovery Following Myelosuppressive Chemotherapy
Measured: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Secondary outcomes (11)
Serum Marker Levels of Inflammation Erythrocyte Sedimentation Rate (ESR; mm/hr) During Cycles of Chemotherapy
Measured: Once before treatment starts and then four more times while the study drug is being taken, an 8 - 16 week period if there are no chemotherapy delays
Number of Days That Participants Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment
This includes hearing loss/tinnitus, motor neuropathy, oral mucositis
Measured: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Number of Participants Who Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment
This includes hearing loss/tinnitus, motor neuropathy, oral mucositis
Measured: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Severity of Adverse Events That Are Commonly Caused by Chemotherapy Treatment Based on CTCAE Severity Criteria
This includes hearing loss/tinnitus, motor neuropathy, oral mucositis
Measured: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Number of Days That Participants Are Hospitalized or Have Prolonged Hospitalization Due to an Adverse Event
Measured: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Number of Days That Planned Cancer Treatment is Delayed Due to an Adverse Event
Measured: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Percentage of Participants Requiring Reduced Treatment Doses Due to an Adverse Event
Measured: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Number of Days That Antimicrobial Treatment is Administered
Measured: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Number of Cycles Where Granulocyte-colony Stimulating Factor (G-CSF) is Administered
Measured: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Number of Times That a Blood Product is Administered for Anemia, Decreased Platelets, Abnormal Bleeding, or the Subject's Best Interest
Measured: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Serum Marker Levels of Inflammation C-reactive Protein (CRP; mg/dL) During Cycles of Chemotherapy
Measured: Once before treatment starts and then four more times while the study drug is being taken, an 8 - 16 week period if there are no chemotherapy delays
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startAug 2016
- Primary completionSep 2021
- Study completionSep 2021
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Petersen, MD, University of Virginia
- Investigators
- William C. Petersen, Jr., M.D., Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624388
- Sponsor's protocol ID
- 17588
- Acronym
- UVA-Gen001
- Status last verified
- May 2024
- First submitted
- 27 Oct 2015
- Last updated
- 6 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Pilot Study of Genistein Supplementation in Pediatric Cancer Patients Receiving Myelosuppressive Chemotherapy
- ClinicalTrials.gov ID
- NCT02624388
- Acronym / sponsor ID
- UVA-Gen001 / 17588
- Conditions
- Lymphoma, Childhood Lymphoma, Solid Tumor, Childhood Solid Tumor, Neuroblastoma, Ewing Sarcoma
- Keywords
- Genistein, Soy, Chemotherapy side-effects, Pediatric Cancer, Isoflavone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Sep 2021 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 8 Dec 2015 (estimated)
- Results
- Posted 6 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Toxicities related to pediatric cancer treatment can lead to significant illness, organ damage, treatment delays, increased health care cost, and decrease in quality of life. Such toxicities are largely due to tissue damage sustained by chemotherapy, and strategies designed to limit such cellular damage to normal tissues may reduce therapy-related morbidity and mortality. In addition to their in vitro and in vivo anti-cancer effects, naturally occurring soy isoflavones have anti-inflammatory and anti-oxidant properties, and have been shown to reduce side effects of therapy in adult oncology clinical trials. This study will examine the effect of genistein, the major isoflavone component in soybeans and the most extensively studied of the soy isoflavones, on short-term side effects of myelosuppressive chemotherapy in pediatric cancer patients. Subjects will be randomized to receive either: a) 30 mg genistein daily throughout chemotherapy Cycles 1 and 2 and placebo during chemotherapy Cycles 3 and 4; or b) placebo daily during chemotherapy Cycles 1 and 2 and 30 mg genistein daily during chemotherapy Cycles 3 and 4. Investigators hypothesize that subjects will have fewer short-term therapy-related side effects during cycles of chemotherapy given in conjunction with genistein supplementation than cycles given with placebo.
Detailed description
This is a multi-center, randomized, double blind, placebo-controlled crossover study to evaluate the effect of soy isoflavones on the short term untoward effects of myelosuppressive chemotherapy used to treat pediatric cancers. Newly diagnosed cancer patients aged 1-21 years will be registered to the study and informed consent will be obtained prior to any study-related procedures. Stratification will be based on length of chemotherapy cycles, between 14 day and 21 day cycles. Within strata registered subjects will be randomized 1:1 to one of two schedules:
Arm A: Subjects will receive genistein daily throughout chemotherapy cycles 1 and 2, and placebo during chemotherapy cycles 3 and 4
Arm B: Subjects will receive placebo daily throughout chemotherapy cycles 1 and 2, and genistein during chemotherapy cycles 3 and 4
Subjects will be assessed for safety and efficacy during each cycle with clinical labs, cytokine panels, and physical exams. Drug compliance will be monitored by use of a patient diary as well as monitoring of serum genistein levels. Adverse events will be monitored starting on Cycle 1 Day 1 through 30 days following the last day of protocol therapy (genistein/placebo).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Genistein followed by Placebo | Experimental | Drug: Genistein, Drug: PlaceboGenistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4 |
| Arm B: Placebo followed by Genistein | Experimental | Drug: Genistein, Drug: PlaceboPlacebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4 |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Newly diagnosed solid tumor or lymphoma with histological verification
- Age 1 - 21 years at time of diagnosis
- Karnofsky/Lanksy performance score of ≥ 50
- Able to tolerate enteral medication administration
- Planned chemotherapeutic regimen for a patient must meet all of the following criteria:
Key exclusion criteria (17 listed)
- Known allergy to soy or any soy-based food or supplement
- Unable or unwilling to discontinue consuming prohibited soy-based food or supplements while participating in this study
- Pre-existing neutropenia or neutrophil qualitative or quantitative disorder
- Pre-existing cytopenia or bone marrow failure syndrome
- History of gastric or duodenal ulcers or hyperacidity syndromes
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 |
|---|---|---|
| GenisteinAlso: 5, 7-dihydroxy-3-(4-hydroxyphenyl)-4H-1-benzopyran-4-one, i-cool tablets containing 30 mg geniVida™Estrogen-like compound (isoflavone) derived from soybeans | Drug | Arm A: Genistein followed by Placebo, Arm B: Placebo followed by Genistein |
| PlaceboPill that contains no medicine | Drug | Arm A: Genistein followed by Placebo, Arm B: Placebo followed by Genistein |
Primary outcome
Time to Neutrophil Count Recovery Following Myelosuppressive Chemotherapy
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
11 secondary outcomes
Serum Marker Levels of Inflammation Erythrocyte Sedimentation Rate (ESR; mm/hr) During Cycles of Chemotherapy
Time frame: Once before treatment starts and then four more times while the study drug is being taken, an 8 - 16 week period if there are no chemotherapy delays
Number of Days That Participants Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Number of Participants Who Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Severity of Adverse Events That Are Commonly Caused by Chemotherapy Treatment Based on CTCAE Severity Criteria
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Number of Days That Participants Are Hospitalized or Have Prolonged Hospitalization Due to an Adverse Event
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Number of Days That Planned Cancer Treatment is Delayed Due to an Adverse Event
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Percentage of Participants Requiring Reduced Treatment Doses Due to an Adverse Event
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Number of Days That Antimicrobial Treatment is Administered
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Number of Cycles Where Granulocyte-colony Stimulating Factor (G-CSF) is Administered
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Number of Times That a Blood Product is Administered for Anemia, Decreased Platelets, Abnormal Bleeding, or the Subject's Best Interest
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Serum Marker Levels of Inflammation C-reactive Protein (CRP; mg/dL) During Cycles of Chemotherapy
Time frame: Once before treatment starts and then four more times while the study drug is being taken, an 8 - 16 week period if there are no chemotherapy delays
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
William C. Petersen, Jr., M.D. principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Genistein in people with Lymphoma and Childhood Lymphoma, run by University of Virginia at 1 site in United States.
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 12 inclusion and 17 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: stopped early, as of the sponsor's last update on 6 May 2024. 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 United States. 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 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?
Yes. Results are posted in the registry (first posted 6 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Neutrophil Count Recovery Following Myelosuppressive Chemotherapy (time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays). 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 6 May 2024.