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

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.

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.

Eligibility Criteria:
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