Nordihydroguaiaretic Acid in Treating Patients With Nonmetastatic Relapsed Prostate Cancer

NCT00313534 | Terminated Phase 1 DMC

• 3 other identifiers: CDR0000455645UCSF-035510UCSF-H45860-23712-02A
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity as measured by CTC v3.0

Secondary Outcomes (2)

• Maximum tolerated dose

• Prostate-specific antigen (PSA) at baseline and on day 1 of each course

Interventions

masoprocol DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Masoprocol

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Lignans; Benzyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols

Study Officials

• Charles Ryan, MD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2006
• First Posted: April 12, 2006
• Study Start: June 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: October 11, 2012

Record last verified: 2012-10

Locations

US (1)