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Nordihydroguaiaretic Acid in Treating Patients With Nonmetastatic Relapsed Prostate Cancer

This study has been terminated.
(Ran out of drug)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00313534
First Posted: April 12, 2006
Last Update Posted: October 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose

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.


Condition Intervention Phase
Prostate Cancer Drug: masoprocol Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of NDGA in Patients With Non-Metastatic Biochemically Relapsed Prostate Cancer

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Dose-limiting toxicity as measured by CTC v3.0

Secondary Outcome Measures:
  • Maximum tolerated dose
  • Prostate-specific antigen (PSA) at baseline and on day 1 of each course

Enrollment: 15
Study Start Date: June 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313534


Locations
United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Investigators
Study Chair: Charles Ryan, MD University of California, San Francisco
  More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00313534     History of Changes
Other Study ID Numbers: CDR0000455645
UCSF-035510
UCSF-H45860-23712-02A
First Submitted: April 11, 2006
First Posted: April 12, 2006
Last Update Posted: October 11, 2012
Last Verified: October 2012

Keywords provided by University of California, San Francisco:
recurrent prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage I prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Masoprocol
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Lipoxygenase Inhibitors
Enzyme Inhibitors
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents