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| Sponsor: | Masonic Cancer Center, University of Minnesota |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00769990 |
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 (Skin) Metastatic Cancer Pain Prostate Cancer |
Dietary Supplement: genistein Other: questionnaire administration Procedure: pain therapy Procedure: quality-of-life assessment Radiation: radiation therapy |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Active Control |
| 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2008 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant solid tumor, including any of the following:
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
Eligible treatment sites include any of following:
Weight-bearing sites:
Non-weight-bearing sites:
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
Hormone receptor status (for patients with breast cancer):
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
More than 90 days since prior intravenous bisphosphonate therapy
Contacts and Locations| United States, Minnesota | |
| Masonic Cancer Center at University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 | |
| Veterans Affairs Medical Center - Minneapolis | Recruiting |
| Minneapolis, Minnesota, United States, 55417 | |
| Contact: Clinical Trials Office - Veterans Affairs Medical Center - Min 612-467-2800 | |
| Principal Investigator: | Shalamar Sibley, MD, MPH | Masonic Cancer Center, University of Minnesota |
More Information
| 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: | October 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00769990 History of Changes |
| Health Authority: | Unspecified |
|
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 |
|
Anticarcinogenic Agents Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Prostatic Diseases Genital Neoplasms, Male Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Urologic Neoplasms Protein Kinase Inhibitors Hormones Melanoma Neoplastic Processes |
Pathologic Processes Neoplasms by Site Urologic Diseases Respiratory Tract Diseases Lung Neoplasms Kidney Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Phytoestrogens Neoplasm Metastasis Nevi and Melanomas Kidney Diseases Breast Diseases Respiratory Tract Neoplasms Estrogens |