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Cholecalciferol and Genistein in Treating Patients Undergoing External-Beam Radiation Therapy for Bone Metastases
This study has been suspended.
First Received: October 8, 2008   Last Updated: May 2, 2009   History of Changes
Sponsors and Collaborators: Masonic Cancer Center, University of Minnesota
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00769990
  Purpose

RATIONALE: Cholecalciferol and 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 giving cholecalciferol together with 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 (Skin)
Metastatic Cancer
Pain
Prostate Cancer
Dietary Supplement: cholecalciferol
Dietary Supplement: genistein
Other: questionnaire administration
Procedure: pain therapy
Procedure: quality-of-life assessment
Radiation: radiation therapy
Phase I
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Dietary Supplements Diets Kidney Cancer Lung Cancer Melanoma Prostate Cancer Radiation Therapy
Drug Information available for: Cholecalciferol Genistein
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Active Control
Official Title: Phase I-II Trial of Vitamin D (Cholecalciferol) and Genistein in Subjects Receiving Palliative External Beam Radiation Therapy for Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]
  • Frequency of severe (grade 3) toxicities [ Designated as safety issue: Yes ]

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 ]

Estimated Enrollment: 30
Study Start Date: September 2008
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To determine whether cholecalciferol and genistein are 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 cholecalciferol and 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

DISEASE CHARACTERISTICS:

  • 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 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

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • Karnofsky performance status 40-100%
  • Life expectancy ≥ 3 months
  • ALT normal
  • Bilirubin normal
  • Corrected serum calcium ≤ 10.4 mg/dL (≤ 10.8 mg/dL if < 20 years of age)
  • 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

PRIOR CONCURRENT THERAPY:

  • More than 90 days since prior radionuclides
  • More than 30 days since prior systemic radioisotopes for pain, including Strontium-90 (^90Sr) and Samarium (^153Sm)
  • More than 30 days since prior antibiotics
  • More than 30 days since prior initiation of systemic therapy (e.g., hormonal therapy, chemotherapy, or immunotherapy)
  • No prior radiotherapy or palliative surgery to the painful sites
  • No concurrent surgical fixation of the bone
  • No concurrent treatment to the skull, hands, or feet
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769990

Locations
United States, Minnesota
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Shalamar Sibley, MD, MPH Masonic Cancer Center, University of Minnesota
  More Information

Additional Information:
No publications provided

Responsible Party: Masonic Cancer Center at University of Minnesota ( Shalamar Sibley )
Study ID Numbers: CDR0000615124, UMN-2008LS035, UMN-0803M29541
Study First Received: October 8, 2008
Last Updated: May 2, 2009
ClinicalTrials.gov Identifier: NCT00769990     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Anticarcinogenic Agents
Thoracic Neoplasms
Prostatic Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Bone Density Conservation Agents
Urologic Neoplasms
Protein Kinase Inhibitors
Hormones
Lung Neoplasms
Neoplasm Metastasis
Neuroepithelioma
Kidney Diseases
Breast Diseases
Cholecalciferol
Breast Neoplasms
Genital Diseases, Male
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Vitamin D
Lung Diseases
Nevus
Prostatic Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Urinary Tract Neoplasm
Genital Neoplasms, Male
Quality of Life

Additional relevant MeSH terms:
Thoracic Neoplasms
Anticarcinogenic Agents
Molecular Mechanisms of Pharmacological Action
Prostatic Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Bone Density Conservation Agents
Urologic Neoplasms
Protein Kinase Inhibitors
Hormones
Neoplasms by Site
Pathologic Processes
Lung Neoplasms
Therapeutic Uses
Neoplasm Metastasis
Kidney Diseases
Breast Diseases
Cholecalciferol
Breast Neoplasms
Genital Diseases, Male
Carcinoma
Neuroectodermal Tumors
Neoplasms
Lung Diseases
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Genital Neoplasms, Male
Antineoplastic Agents
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 07, 2009