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Nordihydroguaiaretic Acid in Treating Patients With Nonmetastatic Relapsed Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
masoprocol
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring recurrent prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage I prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • UCSF Comprehensive Cancer Center

Outcomes

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

Full Information

First Posted
April 11, 2006
Last Updated
October 9, 2012
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00313534
Brief Title
Nordihydroguaiaretic Acid in Treating Patients With Nonmetastatic Relapsed Prostate Cancer
Official Title
A Phase I Study of NDGA in Patients With Non-Metastatic Biochemically Relapsed Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
Ran out of drug
Study Start Date
June 2005 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
recurrent prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage I prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
masoprocol
Primary Outcome Measure Information:
Title
Dose-limiting toxicity as measured by CTC v3.0
Secondary Outcome Measure Information:
Title
Maximum tolerated dose
Title
Prostate-specific antigen (PSA) at baseline and on day 1 of each course

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Ryan, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

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Nordihydroguaiaretic Acid in Treating Patients With Nonmetastatic Relapsed Prostate Cancer

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