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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Breast Cancer, Kidney Cancer, Lung Cancer, Melanoma, Metastatic Cancer, Pain, Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: genistein
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genistein<br>Patients treated with Genistein who are going to undergo palliative radiation treatments for painful boney metastases. | Dietary Supplement: genistein<br>* Genistein will be taken orally once daily as 500 mg capsules throughout the study (60 days).<br>* Other names: Bonistein;Radiation: radiation therapy<br>* A course of palliative external beam radiation therapy -performed within 8 weeks prior to start of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Frequency of severe (grade 3) toxicities | At completion of first 6 patients | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone metastases, pain, recurrent breast cancer, stage IV breast cancer, recurrent prostate cancer, stage IV prostate cancer, recurrent melanoma, stage IV melanoma, recurrent renal cell cancer, stage IV renal cell cancer, recurrent non-small cell lung cancer, stage IV non-small cell lung cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer