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

University of Minnesota (UMN)

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Metastatic Cancer

Breast Cancer

Melanoma

Lung Cancer

Kidney Cancer

Prostate Cancer

Pain

Treatments

Radiation: radiation therapy

Dietary Supplement: genistein

Study type

Interventional

Funder types

Other

Identifiers

NCT00769990

UMN-0803M29541 (Other Identifier)

2008LS035

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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