Nordihydroguaiaretic Acid in Treating Patients With Nonmetastatic Relapsed Prostate Cancer

NCT ID: NCT00313534

Last Updated: 2012-10-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2006-10-31

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.

Conditions

Prostate Cancer

Keywords

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

Study Design

• Primary Study Purpose: TREATMENT

Interventions

masoprocol

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Ryan, MD

Role: STUDY_CHAIR

University of California, San Francisco

Locations

UCSF Comprehensive Cancer Center

San Francisco, California, United States

Countries

United States

Other Identifiers

UCSF-035510

Identifier Type: -

Identifier Source: secondary_id

UCSF-H45860-23712-02A

Identifier Type: -

Identifier Source: secondary_id

CDR0000455645

Identifier Type: -

Identifier Source: org_study_id