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Nordihydroguaiaretic Acid in Treating Patients With Nonmetastatic Relapsed Prostate Cancer

A Phase I Study of NDGA in Patients With Non-Metastatic Biochemically Relapsed Prostate Cancer

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00313534
Enrollment
15
Registered
2006-04-12
Start date
2005-06-30
Completion date
2006-10-31
Last updated
2012-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage I prostate cancer

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.

Interventions

DRUGmasoprocol

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of California, San Francisco
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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)

Design outcomes

Primary

MeasureTime frame
Dose-limiting toxicity as measured by CTC v3.0

Secondary

MeasureTime frame
Maximum tolerated dose
Prostate-specific antigen (PSA) at baseline and on day 1 of each course

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026