Status:
WITHDRAWN
Genistein in Treating Patients Undergoing External-Beam Radiation Therapy for Bone Metastases
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Breast Cancer
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 se...
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00769990
Start Date
September 1 2008
End Date
April 1 2010
Last Update
December 13 2017
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