Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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This study has been withdrawn prior to enrollment.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

October 8, 2008
July 1, 2011
September 2008
November 2009   (final data collection date for primary outcome measure)
Safety [ Time Frame: At completion of first 6 patients ] [ Designated as safety issue: Yes ]
Frequency of severe (grade 3) toxicities
  • Safety [ Designated as safety issue: Yes ]
  • Frequency of severe (grade 3) toxicities [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00769990 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Genistein in Treating Patients Undergoing External-Beam Radiation Therapy for Bone Metastases
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

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Kidney Cancer
  • Lung Cancer
  • Melanoma
  • Metastatic Cancer
  • Pain
  • Prostate Cancer
  • 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.
Experimental: Genistein
Patients treated with Genistein who are going to undergo palliative radiation treatments for painful boney metastases.
Interventions:
  • Dietary Supplement: genistein
  • Radiation: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
April 2010
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00769990
2008LS035, UMN-0803M29541
Yes
Shalamar Sibley, Masonic Cancer Center at University of Minnesota
Masonic Cancer Center, University of Minnesota
Not Provided
Principal Investigator: Shalamar Sibley, MD, MPH Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP