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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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

Other trials in United States

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.

  1. Dose-limiting toxicity as measured by CTC v3.0

Secondary outcomes (2)
  1. Maximum tolerated dose

  2. 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.

  1. First posted12 Apr 2006 (estimated)
  2. Study startJun 2005
  3. Primary completionOct 2006
  4. Study completionOct 2006

Why it stopped: Ran out of drug

Resources

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)
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

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.

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