Nordihydroguaiaretic Acid in Treating Patients With Nonmetastatic Relapsed Prostate Cancer

• Status: Terminated
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: National Cancer Institute (NCI)
• Treatments: Masoprocol

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)