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

This study has been withdrawn prior to enrollment.
(No patient accrual.)
Sponsor:
Information provided by:
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00769990
First received: October 8, 2008
Last updated: July 1, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Kidney Cancer
Lung Cancer
Melanoma
Metastatic Cancer
Pain
Prostate Cancer
Dietary Supplement: genistein
Radiation: radiation therapy
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Safety [ Time Frame: At completion of first 6 patients ] [ Designated as safety issue: Yes ]
    Frequency of severe (grade 3) toxicities


Secondary Outcome Measures:
  • Time to pain relief, duration of pain relief, and degree of pain relief [ Designated as safety issue: No ]
  • Incidence of pathologic fractures [ Designated as safety issue: No ]
  • Effect of treatment on quality of life measures as assessed by the BPI and FACT-G [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2008
Study Completion Date: April 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Genistein
Patients treated with Genistein who are going to undergo palliative radiation treatments for painful boney metastases.
Dietary Supplement: genistein
Genistein will be taken orally once daily as 500 mg capsules throughout the study (60 days).
Other Name: Bonistein
Radiation: radiation therapy
A course of palliative external beam radiation therapy -performed within 8 weeks prior to start of the study.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769990

Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Shalamar Sibley, MD, MPH Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Shalamar Sibley, Masonic Cancer Center at University of Minnesota
ClinicalTrials.gov Identifier: NCT00769990     History of Changes
Other Study ID Numbers: 2008LS035, UMN-0803M29541
Study First Received: October 8, 2008
Last Updated: July 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Masonic Cancer Center, University of Minnesota:
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

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Renal Cell
Kidney Neoplasms
Lung Neoplasms
Melanoma
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Prostatic Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes

ClinicalTrials.gov processed this record on July 24, 2014