Genistein in Reducing Side Effects of Chemotherapy in Pediatric Patients with Solid Tumors or Lymphoma
- Newly diagnosed solid tumor or lymphoma with histological verification
- Performance score minimum requirement is >= 50 on Karnofsky/Lanksy performance scale
- Able and willing to comply with all study related procedures
- Able to tolerate enteral drug administration
- Planned chemotherapeutic regimen for subject must meet all of the following criteria: * A known myelosuppressive regimen which includes a combination of at least two of the following agents: actinomycin, carboplatin, cisplatin, cyclophosphamide, daunorubicin, doxorubicin, etoposide, ifosfamide, topotecan * At least 4 consecutive cycles * Cycle length is either 14 or 21 days * Regimen must either alternate 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); questions regarding whether or not a patient’s chemotherapy plan meets inclusion criteria will be decided by the study chair
- Informed consent must be obtained prior to any study-related procedures; consent will be obtained from a parent or guardian of eligible subjects, or the patient if >= 18 years old; oral assent will be obtained from minor subjects >= 7 years old, unless more stringent requirements are imposed by a site’s local institutional review board
- 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
- Known allergy to soy or any soy-based food or supplement
- Unable or unwilling to discontinue consuming 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
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 x institutional upper limit of normal (IULN)
- Total bilirubin >= 2 x IULN
- International normalized ratio (INR) > 1.5
- A history of gastric or duodenal ulcers or hyperacidity syndromes
- Has a known history of human immunodeficiency virus (HIV)
- Has an active infection requiring systemic therapy
- Planned non-myelosuppressive chemotherapy regimen
- Enrolled on a therapeutic or supportive care clinical trial
- Acute or chronic leukemia diagnosis
- Any condition, in the principal 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
- Pregnant and breastfeeding women are excluded from this study
- Secondary malignancy
- Any condition which might be worsened by estrogen, such as breast cancer, uterine cancer, ovarian cancer, endometriosis or uterine fibroids
I. To estimate the effect of supplementation with genistein on the time to neutrophil count recovery following myelosuppressive chemotherapy.
I. To estimate the effect of supplementation with genistein on short-term side effects of myelosuppressive chemotherapy.
II. To estimate levels of the serum markers of inflammation during cycles of chemotherapy given in conjunction with genistein supplementation versus placebo.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive genistein orally (PO) daily for courses 1-2 and placebo PO daily for courses 3-4. Treatment repeats every 14 or 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive placebo PO daily for courses 1-2 and genistein PO daily for courses 3-4. Treatment repeats every 14 or 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 35 days.
Trial Phase Phase NA
Trial Type Supportive care
University of Virginia Cancer Center
William Carl Petersen
- Primary ID UVA-GEN001
- Secondary IDs NCI-2016-01237, 17588, GEN001
- Clinicaltrials.gov ID NCT02624388