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
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