Clinical trial · Interventional
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
NCT00313534CI-TRIAL-00008258terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Ran out of drug
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| masoprocol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Dose-limiting toxicity as measured by CTC v3.0
Secondary outcomes (2)
- measure
- Maximum tolerated dose
- measure
- Prostate-specific antigen (PSA) at baseline and on day 1 of each course
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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)References
Publications (0)
Data not yet available
No reference posted for this study.