Study of Genistein in Pediatric Oncology Patients (UVA-Gen001)
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Brain Cancer, Brain Cancer, Lymphoma, Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 1 - 21 |
| Updated: | 6/22/2017 |
| Start Date: | August 2016 |
| End Date: | June 2019 |
| Contact: | William C. Petersen, Jr., M.D. |
| Email: | wcp3g@virginia.edu |
| Phone: | 434-924-5105 |
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.
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.
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).
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).
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
We found this trial at
1
site
Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: William C Petersen, Jr., M.D.
Phone: 434-243-0910
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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