Study of Genistein in Pediatric Oncology Patients (UVA-Gen001)

NCT02624388 | Terminated Phase 2 Results DMC

• 1 other identifier: 17588
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Lymphoma; Childhood Lymphoma; Solid Tumor; Childhood Solid Tumor; Neuroblastoma; Ewing Sarcoma; Hodgkin Lymphoma; Non-Hodgkin Lymphoma; Rhabdomyosarcoma; Soft Tissue Sarcoma; Medulloblastoma; Germ Cell Tumor; Wilms Tumor; Brain Neoplasms; Medulloblastoma, Childhood; Neuroectodermal Tumors, Primitive

Keywords

Genistein; Soy; Chemotherapy side-effects; Pediatric Cancer; Isoflavone

Outcome Measures

Primary Outcomes (1)

• Time to Neutrophil Count Recovery Following Myelosuppressive Chemotherapy

  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

  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

  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

  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

  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

  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

Study Arms (2)

Arm A: Genistein followed by Placebo

EXPERIMENTAL

Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4

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

Drug: Genistein; Drug: Placebo

Interventions

Genistein DRUG

Estrogen-like compound (isoflavone) derived from soybeans

Also known as: 5, 7-dihydroxy-3-(4-hydroxyphenyl)-4H-1-benzopyran-4-one, i-cool tablets containing 30 mg geniVida™

Arm A: Genistein followed by Placebo; Arm B: Placebo followed by Genistein

Placebo DRUG

Pill that contains no medicine

Arm A: Genistein followed by Placebo; Arm B: Placebo followed by Genistein

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• At least four consecutive cycles
• Cycle length is either 14 or 21 days
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Lymphoma; Neuroblastoma; Sarcoma, Ewing; Hodgkin Disease; Lymphoma, Non-Hodgkin; Rhabdomyosarcoma; Sarcoma; Medulloblastoma; Neoplasms, Germ Cell and Embryonal; Wilms Tumor; Brain Neoplasms; Neuroectodermal Tumors, Primitive; Neoplasms

Interventions

Genistein

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neuroectodermal Tumors, Primitive, Peripheral; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Myosarcoma; Neoplasms, Muscle Tissue; Glioma; Neoplasms, Complex and Mixed; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: William Petersen
• Organization: UVA Health

wcp3g@uvahealth.org

434-924-8499

Study Officials

• William C. Petersen, Jr., M.D.

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pediatric Novel Therapeutics Program (Hematology/Oncology)

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: December 8, 2015
• Study Start: August 1, 2016
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: May 6, 2024
• Results First Posted: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)