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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

Phase 1/Phase 2
18 Years
Not Enrolling
Breast Cancer, Kidney Cancer, Lung Cancer, Melanoma, Metastatic Cancer, Pain, Prostate Cancer

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Trial Information

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


- 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

- 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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Frequency of severe (grade 3) toxicities

Outcome Time Frame:

At completion of first 6 patients

Safety Issue:


Principal Investigator

Shalamar Sibley, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

September 2008

Completion Date:

April 2010

Related Keywords:

  • Breast Cancer
  • Kidney Cancer
  • Lung Cancer
  • Melanoma
  • Metastatic Cancer
  • Pain
  • Prostate Cancer
  • 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
  • Breast Neoplasms
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Lung Neoplasms
  • Melanoma
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Prostatic Neoplasms