Breast CancerPhase 1/2NCT00769990
Genistein in Treating Patients Undergoing External-Beam Radiation Therapy for Bone Metastases
A Phase 1/2 study testing genistein and radiation therapy in people with Breast Cancer and Kidney Cancer, run by Masonic Cancer Center, University of Minnesota.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Kidney Cancer, Lung Cancer
- What is being tested?
- genistein and radiation therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Apr 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed malignant solid tumor, including any of the following:
- Breast cancer
- Lung cancer
- Kidney cancer
- Melanoma
- Prostate cancer
Show all 48Show fewer
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer, Kidney Cancer, Lung Cancer, Melanoma, Metastatic Cancer, Pain
- Being tested
- genistein, radiation therapy
- 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
- Medical subject headings
- Breast Neoplasms, Kidney Neoplasms, Lung Neoplasms, Melanoma, Neoplasm Metastasis, Pain, Prostatic Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genisteinDietary supplement
Also called Bonistein
Genistein will be taken orally once daily as 500 mg capsules throughout the study (60 days).
radiation therapyRadiation
A course of palliative external beam radiation therapy -performed within 8 weeks prior to start of the study.
| Study group | Role | What they receive |
|---|---|---|
| Genistein | Experimental | Patients treated with Genistein who are going to undergo palliative radiation treatments for painful boney metastases. Receives: Dietary Supplement: genistein; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Frequency of severe (grade 3) toxicities
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionNov 2009
- Study completionApr 2010
Why it stopped: No patient accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shalamar Sibley, MD, MPH, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769990
- Sponsor's protocol ID
- 2008LS035
- Other IDs
- UMN-0803M29541
- Status last verified
- Jul 2011
- First submitted
- 8 Oct 2008
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00769990
- Acronym / sponsor ID
- 2008LS035
- Conditions
- Breast Cancer, Kidney Cancer, Lung Cancer, Melanoma, Metastatic Cancer, Pain
- Keywords
- bone metastases, pain, recurrent breast cancer, stage IV breast cancer, recurrent prostate cancer, stage IV prostate cancer, recurrent melanoma, stage IV melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patient accrual.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 9 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genistein | Experimental | Dietary Supplement: genistein, Radiation: radiation therapyPatients treated with Genistein who are going to undergo palliative radiation treatments for painful boney metastases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (48 listed)
- Histologically confirmed malignant solid tumor, including any of the following:
- 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
- Eligible treatment sites include any of following:
- 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
Key exclusion criteria (8 listed)
- 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
- Prior radiotherapy or palliative surgery to the painful sites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genisteinAlso: BonisteinGenistein will be taken orally once daily as 500 mg capsules throughout the study (60 days). | Dietary supplement | Genistein |
| radiation therapyA course of palliative external beam radiation therapy -performed within 8 weeks prior to start of the study. | Radiation | Genistein |
Primary outcome
Safety
Time frame: At completion of first 6 patients
Frequency of severe (grade 3) toxicities
3 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shalamar Sibley, MD, MPH principal investigator
Masonic Cancer Center, University of Minnesota
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing genistein and radiation therapy in people with Breast Cancer and Kidney Cancer, run by Masonic Cancer Center, University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 48 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: At completion of first 6 patients). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017.