Prostate CancerPhase 1NCT00305747
Diindolylmethane in Treating Patients With Nonmetastatic Prostate Cancer That Has Not Responded To Previous Hormone Therapy
A Phase 1 study testing BR-DIM in people with Prostate Cancer, run by Barbara Ann Karmanos Cancer Institute at 2 sites in United States.
Trial summary
RATIONALE: Diindolylmethane may slow the growth of prostate cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of diindolylmethane in treating patients with nonmetastatic prostate cancer that has not responded to previous hormone therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- BR-DIM
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2005to Sep 2010
- Phase
- Phase 1
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically proven adenocarcinoma of the prostate
- Prostate specific antigen (PSA)-only failure after local therapy (surgery, radiation therapy, brachytherapy, or cryotherapy)
- Rising PSA despite androgen-deprivation therapy with castrate levels of testosterone (< 50 ng/dL)
- Two successive rising PSA levels at least 1 week apart
- PSA ≥ 5 ng/mL
- Patients with a history of combined hormonal therapy must continue luteinizing-hormone releasing-hormone agonist treatment but must demonstrate rising PSA after anti-androgen withdrawal
- No evidence of distant metastasis by bone scan and CT scan
- No known brain metastases requiring active therapy
PATIENT CHARACTERISTICS:
- ECOG performance status ≤ 3
- Life expectancy ≥ 12 weeks
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8.0 g/dL
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- SGOT and/or SGPT ≤ 2.5 times ULN AND alkaline phosphatase normal OR alkaline phosphatase ≤ 4 times ULN AND SGOT and/or SGPT normal
- Creatinine clearance ≥ 60 mL/min OR creatinine normal
- Fertile patients must use effective contraception
- None of the following conditions within the past 6 months:
- Myocardial infarction
- Severe or unstable angina
- Symptomatic congestive heart failure
- Cerebrovascular accident or transient ischemic attack
- Coronary/peripheral artery bypass grafting
- No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 28 days since prior radiotherapy
- At least 28 days since prior investigational agents for treatment of prostate cancer
- At least 4 weeks since prior flutamide
- At least 6 weeks since prior bicalutamide
- No other concurrent antineoplastic agents
- No concurrent warfarin-related anticoagulants
- No concurrent proton-pump inhibitor drugs for gastroesophageal reflux disease (e.g., rabeprazole, esomeprazole magnesium, lansoprazole, omeprazole, or pantoprazole sodium)
- No concurrent micronutrient supplements or dietary soy products
- One daily multivitamin allowed
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Weisberg Cancer Treatment Center
Detroit, Michigan, 48334
About this study
Official title: Phase I Study of Bioresponse-dim in Non-Metastatic, Hormone-Refractory Prostate Cancer Patients With Rising Serum PSA
RATIONALE: Diindolylmethane may slow the growth of prostate cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of diindolylmethane in treating patients with nonmetastatic prostate cancer that has not responded to previous hormone therapy.
Read the detailed description
OBJECTIVES:
Primary
- Establish the maximum tolerated dose, dose-limiting toxicity, and a recommended phase II dose of absorption-enhanced diindolylmethane (BioResponse-DIM^® [BR-DIM]) in patients with nonmetastatic, hormone-refractory prostate cancer and rising serum prostate-specific antigen (PSA) levels.
- Evaluate the toxicities of BR-DIM.
Secondary
- Evaluate the plasma pharmacokinetics of twice daily oral administration of BR-DIM in this patient population.
- Evaluate the effect of BR-DIM supplementation on serum PSA level.
- Correlate changes in expression levels of lymphocytes NF-kB with serum PSA levels in patients taking BR-DIM supplementation.
- Determine quality of life measures in patients taking BR-DIM supplementation.
OUTLINE: This is an open-label, dose-escalation study.
Patients receive oral absorption-enhanced absorption-enhanced diindolylmethane (BioResponse-DIM^® [BR-DIM]) twice daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BR-DIM until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
Quality of life is assessed at baseline, on day 1 of each course, and at the completion of study therapy.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- BR-DIM
- Keywords
- recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, adenocarcinoma of the prostate, stage IV prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR-DIMDrug
Also called oral microencapsulated diindolylmethane
75 mg orally (po) twice daily. May continue treatment for 12 months, however patients will be taken off study if their disease progresses, or have intolerable side effects.
| Study group | Role | What they receive |
|---|---|---|
| BR-DIM | Experimental | BR-DIM will be administered at a starting dose of 75 mg po twice daily. Patients will be instructed to take tablets twice daily with 8 ozs. of water, with/without food. A study calendar will be provided and patients will be asked to fill the appropriate boxes when they take their study capsules. One treatment cycle is 28 days. Receives: Drug: BR-DIM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD), Dose limiting toxicity (DLT) & toxicities during study and for 30 days after
Measured: During study and for 30 days after
Secondary outcomes (4)
Plasma pharmacokinetics as measured by occurrences of toxicity
Measured: At baseline; Cycle 1 Day 1 at 20, 60, 120, 180, 240, and 480 minutes
Serum prostate specific antigen as measured by complete plasma concentration-time profile
Measured: At baseline, Day 1 of each cycle and at study termination
Correlate changes in expression levels of NF-kB lymphocytes in with serum prostate specific antigen levels by serum prostate specific antigen level
Measured: At baseline, Cycle 2 and study termination
Quality of life (QOL) by Life Orient. Test-Rev., Duke-UNC Func. Social Support Questionnaire, EORTC QOL questionnaire, QLQ-PR25 questionnaire, and the Hosp. Anxiety & Depression Scale
Measured: At baseline, day 1 of each cycle and study termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2006 (estimated)
- Study startAug 2005
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Elisabeth Heath, Barbara Ann Karmanos Cancer Institute
- Investigators
- Elisabeth I. Heath, MD, Study chair, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00305747
- Sponsor's protocol ID
- CDR0000462637
- Other IDs
- P30CA022453, WSU-D-2979, WSU-0507002581
- Status last verified
- Jan 2014
- First submitted
- 21 Mar 2006
- Last updated
- 15 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Bioresponse-dim in Non-Metastatic, Hormone-Refractory Prostate Cancer Patients With Rising Serum PSA
- ClinicalTrials.gov ID
- NCT00305747
- Acronym / sponsor ID
- CDR0000462637
- Conditions
- Prostate Cancer
- Keywords
- recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, adenocarcinoma of the prostate, stage IV prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2005
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 22 Mar 2006 (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: Diindolylmethane may slow the growth of prostate cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of diindolylmethane in treating patients with nonmetastatic prostate cancer that has not responded to previous hormone therapy.
Detailed description
OBJECTIVES:
Primary
- Establish the maximum tolerated dose, dose-limiting toxicity, and a recommended phase II dose of absorption-enhanced diindolylmethane (BioResponse-DIM^® [BR-DIM]) in patients with nonmetastatic, hormone-refractory prostate cancer and rising serum prostate-specific antigen (PSA) levels.
- Evaluate the toxicities of BR-DIM.
Secondary
- Evaluate the plasma pharmacokinetics of twice daily oral administration of BR-DIM in this patient population.
- Evaluate the effect of BR-DIM supplementation on serum PSA level.
- Correlate changes in expression levels of lymphocytes NF-kB with serum PSA levels in patients taking BR-DIM supplementation.
- Determine quality of life measures in patients taking BR-DIM supplementation.
OUTLINE: This is an open-label, dose-escalation study.
Patients receive oral absorption-enhanced absorption-enhanced diindolylmethane (BioResponse-DIM^® [BR-DIM]) twice daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BR-DIM until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
Quality of life is assessed at baseline, on day 1 of each course, and at the completion of study therapy.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BR-DIM | Experimental | Drug: BR-DIMBR-DIM will be administered at a starting dose of 75 mg po twice daily. Patients will be instructed to take tablets twice daily with 8 ozs. of water, with/without food. A study calendar will be provided and patients will be asked to fill the appropriate boxes when they take their study capsules. One treatment cycle is 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| BR-DIMAlso: oral microencapsulated diindolylmethane75 mg orally (po) twice daily. May continue treatment for 12 months, however patients will be taken off study if their disease progresses, or have intolerable side effects. | Drug | BR-DIM |
Primary outcome
Maximum tolerated dose (MTD), Dose limiting toxicity (DLT) & toxicities during study and for 30 days after
Time frame: During study and for 30 days after
4 secondary outcomes
Plasma pharmacokinetics as measured by occurrences of toxicity
Time frame: At baseline; Cycle 1 Day 1 at 20, 60, 120, 180, 240, and 480 minutes
Serum prostate specific antigen as measured by complete plasma concentration-time profile
Time frame: At baseline, Day 1 of each cycle and at study termination
Correlate changes in expression levels of NF-kB lymphocytes in with serum prostate specific antigen levels by serum prostate specific antigen level
Time frame: At baseline, Cycle 2 and study termination
Quality of life (QOL) by Life Orient. Test-Rev., Duke-UNC Func. Social Support Questionnaire, EORTC QOL questionnaire, QLQ-PR25 questionnaire, and the Hosp. Anxiety & Depression Scale
Time frame: At baseline, day 1 of each cycle and study termination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2014.
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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.
Elisabeth I. Heath, MD study chair
Barbara Ann Karmanos Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BR-DIM in people with Prostate Cancer, run by Barbara Ann Karmanos Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 15 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum tolerated dose (MTD), Dose limiting toxicity (DLT) & toxicities during study and for 30 days after (time frame: During study and for 30 days after). 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 15 Jan 2014.