Prostate CancerPhase 1NCT00313534
Nordihydroguaiaretic Acid in Treating Patients With Nonmetastatic Relapsed Prostate Cancer
A Phase 1 study testing masoprocol in people with Prostate Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
RATIONALE: Nordihydroguaiaretic acid may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of nordihydroguaiaretic acid in treating patients with nonmetastatic relapsed prostate cancer. 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?
- masoprocol
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Oct 2006
- 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 confirmed prostate cancer, meeting 1 of the following criteria:
- Androgen-dependent disease (testosterone ≥ 250 ng/mL)
- Androgen-independent disease (testosterone < 50 ng/mL)
- Received prior definitive therapy for primary prostate cancer comprising any of the following:
- External-beam radiotherapy with or without hormonal therapy
- Brachytherapy with or without pelvic external-beam radiotherapy or hormonal therapy
- Radical prostatectomy with or without adjuvant or salvage radiotherapy
- Cryotherapy
- Must have evidence of disease progression, as evidenced by elevated prostate-specific antigen (PSA) that has risen serially from post-definitive therapy nadir on 2 determinations taken ≥ 1 week apart
- Elevated PSA, meeting 1 of the following criteria:
- At least 1.0 ng/mL post radiotherapy or cryotherapy
- At least 4 ng/mL post radical prostatectomy
- Must show disease progression after discontinuation of the antiandrogen (for patients with androgen-dependent disease receiving antiandrogen as part of primary androgen ablation)
- No metastatic disease, confirmed by negative bone scan and negative CT scan or MRI of abdomen/pelvis
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Absolute neutrophil count ≥ 1,500/mm³
- Hemoglobin ≥ 8.0 g/dL
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- AST ≤ 1.5 times ULN
- No other medical condition that would interfere with study therapy or compliance
- No other active malignancy except previously treated squamous cell or basal cell skin cancer or cancer that has been treated and considered to be at < 30% risk of relapse
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 8 weeks since prior strontium-chloride Sr 89
- More than 4 weeks since first dose of bisphosphonates
- More than 4 weeks since prior major surgery or radiotherapy
- At least 4 weeks since prior hormonal agents, including megestrol or steroids
- Concurrent luteinizing hormone-releasing hormone analogs allowed to maintain castrate levels of testosterone
- At least 4 weeks since prior and no concurrent saw palmetto, finasteride, or any herbal agent intended to lower PSA
- Prior adjuvant or neoadjuvant androgen-deprivation therapy allowed for androgen-dependent prostate cancer provided that all of the following are met:
- No more than 8 months of androgen deprivation
- At least 12 months since last day of effective androgen deprivation
- Testosterone > 250 ng/mL at enrollment
- Prior hormonal therapy, chemotherapy, or investigational therapy for biochemical relapse allowed
- No concurrent chemotherapeutic, immunotherapeutic, or other investigational agents
- No concurrent radiotherapy
- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: A Phase I Study of NDGA in Patients With Non-Metastatic Biochemically Relapsed Prostate Cancer
RATIONALE: Nordihydroguaiaretic acid may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of nordihydroguaiaretic acid in treating patients with nonmetastatic relapsed prostate cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of nordihydroguaiaretic acid (NDGA) in patients with nonmetastatic, biochemically relapsed prostate cancer.
Secondary
- Determine prostate-specific antigen-modulating effects of NDGA in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral nordihydroguaiaretic acid (NDGA) twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of NDGA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- masoprocol
- Keywords
- recurrent prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage I 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.
masoprocolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity as measured by CTC v3.0
Secondary outcomes (2)
Maximum tolerated dose
Prostate-specific antigen (PSA) at baseline and on day 1 of each course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startJun 2005
- Primary completionOct 2006
- Study completionOct 2006
Why it stopped: Ran out of drug
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.
- More trials run by University of California, San FranciscoThe 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
- Primary purpose
- Treatment
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Charles Ryan, MD, Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313534
- Sponsor's protocol ID
- CDR0000455645
- Other IDs
- UCSF-035510, UCSF-H45860-23712-02A
- Status last verified
- Oct 2012
- First submitted
- 11 Apr 2006
- Last updated
- 11 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of NDGA in Patients With Non-Metastatic Biochemically Relapsed Prostate Cancer
- ClinicalTrials.gov ID
- NCT00313534
- Acronym / sponsor ID
- CDR0000455645
- Conditions
- Prostate Cancer
- Keywords
- recurrent prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage I prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Ran out of drug
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 12 Apr 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: Nordihydroguaiaretic acid may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of nordihydroguaiaretic acid in treating patients with nonmetastatic relapsed prostate cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of nordihydroguaiaretic acid (NDGA) in patients with nonmetastatic, biochemically relapsed prostate cancer.
Secondary
- Determine prostate-specific antigen-modulating effects of NDGA in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral nordihydroguaiaretic acid (NDGA) twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of NDGA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| masoprocol | Drug | – |
Primary outcome
Dose-limiting toxicity as measured by CTC v3.0
2 secondary outcomes
Maximum tolerated dose
Prostate-specific antigen (PSA) at baseline and on day 1 of each course
Results and safety
The study was stopped early (reason given: Ran out of drug). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2012.
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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.
Charles Ryan, MD study chair
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing masoprocol in people with Prostate Cancer, run by University of California, San Francisco at 1 site 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: stopped early, as of the sponsor's last update on 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Ran out of drug). Results are not available in the source record.
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?
Dose-limiting toxicity as measured by CTC v3.0. 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 11 Oct 2012.