Genistein in Treating Patients Undergoing External-Beam Radiation Therapy for Bone Metastases

Overview

RATIONALE: Genistein may increase the effectiveness of radiation therapy in treating pain caused by bone metastases. PURPOSE: This phase I/II trial is studying the side effects of genistein and to see how well it works in treating patients undergoing external-beam radiation therapy for pain caused by bone metastases.

Full Title of Study: “Phase I-II Trial of Genistein in Subjects Receiving Palliative External Beam Radiation Therapy for Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2009

Detailed Description

OBJECTIVES: – To determine whether genistein is safe when administered in combination with palliative external beam radiotherapy in patients with osseous metastases. – To determine the time to pain relief, duration of pain relief, and degree of pain relief in patients treated with this regimen. – To determine the incidence of pathologic fractures in patients treated with this regimen. – To determine the effect of this regimen on quality of life measures in these patients. OUTLINE: This is a multicenter study. Patients undergo external beam radiotherapy once daily on days 1-10. Patients also receive oral genistein once daily on days 1-60. Patients complete pain and quality-of-life questionnaires periodically. After completion of study therapy, patients are followed at 30 days.

Interventions

  • Dietary Supplement: genistein
    • Genistein will be taken orally once daily as 500 mg capsules throughout the study (60 days).
  • Radiation: radiation therapy
    • A course of palliative external beam radiation therapy -performed within 8 weeks prior to start of the study.

Arms, Groups and Cohorts

  • Experimental: Genistein
    • Patients treated with Genistein who are going to undergo palliative radiation treatments for painful boney metastases.

Clinical Trial Outcome Measures

Primary Measures

  • Safety
    • Time Frame: At completion of first 6 patients
    • Frequency of severe (grade 3) toxicities

Secondary Measures

  • Time to pain relief, duration of pain relief, and degree of pain relief
  • Incidence of pathologic fractures
  • Effect of treatment on quality of life measures as assessed by the BPI and FACT-G

Participating in This Clinical Trial

Inclusion Criteria

  • Histologically confirmed malignant solid tumor, including any of the following: – Breast cancer – Lung cancer – Kidney cancer – Melanoma – Prostate cancer – Radiographic evidence* of bone metastasis within the past 8 weeks NOTE: *Acceptable studies include plain radiograph, radionuclide bone scan, CT scan, and MRI – Has pain that appears to be related to the radiographically documented metastasis, in the opinion of the treating physician, AND a decision has been made by the responsible clinician that a course of palliative external beam radiotherapy is appropriate treatment – "Worst pain score" of > 5 on a scale of 10 as scored on the pain assessment questionnaire (BPI) (question #3: 0 = no pain; 10 = worst possible pain) OR taking narcotic medications with an oral morphine equivalent dose of > 60 mg/day – No painful metastases to the skull, hands, or feet – Eligible treatment sites include any of following: – Weight-bearing sites: – Pelvis (excluding pubis) – Femur – Sacrum and/or sacroiliac joints – Tibia – Non-weight-bearing sites: – Up to 5 consecutive cervical, thoracic, or lumbar vertebral bodies – Lumbosacral spine – Up to 3 consecutive ribs – Humerus – Fibula – Radius ± ulna – Clavicle – Sternum – Scapula – Pubis – If multiple osseous sites are treated, the treatment site is included as weight-bearing if any of the sites include the pelvis, sacrum, femur, or tibia – Treatment of multiple osseous sites allowed only if those sites can be included in ≤ 3 treatment sites – Patients with painful metastases that are contiguous but do not fit into the definition of a site listed above are eligible but are considered to have 2 treatment sites – No vertebral metastases with clinical or radiographic evidence of spinal cord or cauda equina compression/effacement – No primary hematologic malignancies (e.g., lymphoma) – Hormone receptor status (for patients with breast cancer): – Estrogen receptor-negative tumor – Menopausal status not specified – Karnofsky performance status 40-100% – Life expectancy ≥ 3 months – ALT normal – Bilirubin normal – Serum creatinine normal (≤ 1.8 mg/dL for males and ≤ 1.5 mg/dL for females) – Free T4 and thyroid-stimulating hormone normal – Not pregnant – Negative pregnancy test – Fertile patients must use effective contraception – No pathologic fracture or impending fracture of the treatment site – No history of primary hyperparathyroidism – No malabsorptive disease or chronic diarrhea – No history of sarcoidosis or tuberculosis Exclusion Criteria:

  • Less than 30 days since prior systemic radioisotopes for pain, including Strontium-90 (^90Sr) or Samarium (^153Sm) – Less than 30 days since prior antibiotics – Less than 30 days since prior initiation of systemic therapy (e.g., hormonal therapy, chemotherapy, or immunotherapy) – Less than 90 days since prior intravenous bisphosphonate therapy – Concurrent oral bisphosphonates allowed – Prior radiotherapy or palliative surgery to the painful sites – Concurrent surgical fixation of the bone – Concurrent treatment to the skull, hands, or feet

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Masonic Cancer Center, University of Minnesota
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Shalamar Sibley, MD, MPH, Principal Investigator, Masonic Cancer Center, University of Minnesota

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