Clinical trial NCT00769990: Genistein in Treating Patients Undergoing External-Beam Radiation Therapy for Bone Metastases
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Kidney Cancer
Lung Cancer
Melanoma
Metastatic Cancer
Pain
Prostate Cancer
Keywords: 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
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2008-10-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 see how well it works in treating patients undergoing external-beam radiation therapy for pain caused by bone metastases.

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 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

Primary outcomes:
measure: Safety
timeFrame: At completion of first 6 patients
Secondary outcomes:
measure: Time to pain relief, duration of pain relief, and degree of pain relief
measure: Incidence of pathologic fractures
measure: Effect of treatment on quality of life measures as assessed by the BPI and FACT-G
Other outcomes:
Locations:
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Shalamar Sibley, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: