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

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Brief Title

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

Official Title

A Randomized, Placebo-Controlled Pilot Study of Genistein Supplementation in Pediatric Cancer Patients Receiving Myelosuppressive Chemotherapy

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.
    

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Time to neutrophil count recovery following myelosuppressive chemotherapy

Secondary Outcome

 Serum marker levels of inflammation during cycles of chemotherapy

Condition

Lymphoma

Intervention

Genistein

Study Arms / Comparison Groups

 Arm A: Genistein followed by Placebo
Description:  Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

50

Start Date

August 2016

Completion Date

June 2019

Primary Completion Date

August 2018

Eligibility Criteria

        Inclusion Criteria

          1. Newly diagnosed solid tumor or lymphoma with histological verification

          2. Age 1 - 21 years at time of diagnosis

          3. Karnofsky/Lanksy performance score of ≥ 50

          4. Able to tolerate enteral medication administration

          5. 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

               -  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.

          6. Informed consent or parental permission and assent obtained prior to trial-related
             activities

          7. Able and willing to comply with all study related procedures

          8. 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

        Exclusion Criteria

          1. Known allergy to soy or any soy-based food or supplement

          2. Unable or unwilling to discontinue consuming prohibited soy-based food or supplements
             while participating in this study

          3. Pre-existing neutropenia or neutrophil qualitative or quantitative disorder

          4. Pre-existing cytopenia or bone marrow failure syndrome

          5. History of gastric or duodenal ulcers or hyperacidity syndromes

          6. History of Human Immunodeficiency Virus (HIV)

          7. Has an active infection requiring systemic therapy

          8. Planned treatment does not include myelosuppressive chemotherapy

          9. Enrolled on a therapeutic or supportive care clinical trial within the last 30 days

         10. Current acute or chronic leukemia diagnosis

         11. 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.)

         12. Pregnant or breastfeeding woman

         13. Incarceration

         14. 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

         15. Any condition which might be worsened by estrogen, such as breast cancer, uterine
             cancer, ovarian cancer, endometriosis or uterine fibroids

         16. Any condition, in the investigator's opinion, that would compromise patient safety or
             study outcomes

         17. Anyone who, in the investigator's discretion, would be unwilling or unable to comply
             with study procedures
      

Gender

All

Ages

1 Year - 21 Years

Accepts Healthy Volunteers

No

Contacts

William C. Petersen, Jr., M.D., 434-924-5105, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02624388

Organization ID

17588


Responsible Party

Principal Investigator

Study Sponsor

University of Virginia


Study Sponsor

William C. Petersen, Jr., M.D., Principal Investigator, University of Virginia


Verification Date

June 2017