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

NCT00769990 | Withdrawn Phase 1 DMC

• 2 other identifiers: 2008LS035UMN-0803M29541
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Cancer; Kidney Cancer; Lung Cancer; Melanoma; Metastatic Cancer; Pain; Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety

  Frequency of severe (grade 3) toxicities

  At completion of first 6 patients

Secondary Outcomes (3)

• Time to pain relief, duration of pain relief, and degree of pain relief

• Incidence of pathologic fractures

• Effect of treatment on quality of life measures as assessed by the BPI and FACT-G

Study Arms (1)

Genistein

EXPERIMENTAL

Patients treated with Genistein who are going to undergo palliative radiation treatments for painful boney metastases.

Dietary Supplement: genistein; Radiation: radiation therapy

Interventions

genistein DIETARY_SUPPLEMENT

Genistein will be taken orally once daily as 500 mg capsules throughout the study (60 days).

Also known as: Bonistein

Genistein

radiation therapy RADIATION

A course of palliative external beam radiation therapy -performed within 8 weeks prior to start of the study.

Genistein

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

MeSH Terms

Conditions

Breast Neoplasms; Kidney Neoplasms; Lung Neoplasms; Melanoma; Neoplasm Metastasis; Pain; Prostatic Neoplasms; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Genistein; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics

Study Officials

• Shalamar Sibley, MD, MPH

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: September 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: April 1, 2010
• Last Updated: December 13, 2017

Record last verified: 2011-07