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

This is an interventional supportive care trial for Lymphoma focused on measuring Genistein, Soy, Chemotherapy side-effects, Pediatric Cancer, Isoflavone Read More

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