ClinicalTrials.gov
ClinicalTrials.gov Menu

Diindolylmethane in Treating Patients With Nonmetastatic Prostate Cancer That Has Not Responded To Previous Hormone Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00305747
Recruitment Status : Completed
First Posted : March 22, 2006
Last Update Posted : January 15, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Elisabeth Heath, Barbara Ann Karmanos Cancer Institute

March 21, 2006
March 22, 2006
January 15, 2014
August 2005
September 2010   (Final data collection date for primary outcome measure)
Maximum tolerated dose (MTD), Dose limiting toxicity (DLT) & toxicities during study and for 30 days after [ Time Frame: During study and for 30 days after ]
Not Provided
Complete list of historical versions of study NCT00305747 on ClinicalTrials.gov Archive Site
  • Plasma pharmacokinetics as measured by occurrences of toxicity [ Time Frame: At baseline; Cycle 1 Day 1 at 20, 60, 120, 180, 240, and 480 minutes ]
  • Serum prostate specific antigen as measured by complete plasma concentration-time profile [ Time Frame: At baseline, Day 1 of each cycle and at study termination ]
  • Correlate changes in expression levels of NF-kB lymphocytes in with serum prostate specific antigen levels by serum prostate specific antigen level [ Time Frame: At baseline, Cycle 2 and study termination ]
  • Quality of life (QOL) by Life Orient. Test-Rev., Duke-UNC Func. Social Support Questionnaire, EORTC QOL questionnaire, QLQ-PR25 questionnaire, and the Hosp. Anxiety & Depression Scale [ Time Frame: At baseline, day 1 of each cycle and study termination ]
Not Provided
Not Provided
Not Provided
 
Diindolylmethane in Treating Patients With Nonmetastatic Prostate Cancer That Has Not Responded To Previous Hormone Therapy
Phase I Study of Bioresponse-dim in Non-Metastatic, Hormone-Refractory Prostate Cancer Patients With Rising Serum PSA

RATIONALE: Diindolylmethane may slow the growth of prostate cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of diindolylmethane in treating patients with nonmetastatic prostate cancer that has not responded to previous hormone therapy.

OBJECTIVES:

Primary

  • Establish the maximum tolerated dose, dose-limiting toxicity, and a recommended phase II dose of absorption-enhanced diindolylmethane (BioResponse-DIM^® [BR-DIM]) in patients with nonmetastatic, hormone-refractory prostate cancer and rising serum prostate-specific antigen (PSA) levels.
  • Evaluate the toxicities of BR-DIM.

Secondary

  • Evaluate the plasma pharmacokinetics of twice daily oral administration of BR-DIM in this patient population.
  • Evaluate the effect of BR-DIM supplementation on serum PSA level.
  • Correlate changes in expression levels of lymphocytes NF-kB with serum PSA levels in patients taking BR-DIM supplementation.
  • Determine quality of life measures in patients taking BR-DIM supplementation.

OUTLINE: This is an open-label, dose-escalation study.

Patients receive oral absorption-enhanced absorption-enhanced diindolylmethane (BioResponse-DIM^® [BR-DIM]) twice daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BR-DIM until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.

Quality of life is assessed at baseline, on day 1 of each course, and at the completion of study therapy.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
Drug: BR-DIM
75 mg orally (po) twice daily. May continue treatment for 12 months, however patients will be taken off study if their disease progresses, or have intolerable side effects.
Other Name: oral microencapsulated diindolylmethane
Experimental: BR-DIM
BR-DIM will be administered at a starting dose of 75 mg po twice daily. Patients will be instructed to take tablets twice daily with 8 ozs. of water, with/without food. A study calendar will be provided and patients will be asked to fill the appropriate boxes when they take their study capsules. One treatment cycle is 28 days.
Intervention: Drug: BR-DIM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
Not Provided
September 2010
September 2010   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically proven adenocarcinoma of the prostate
  • Prostate specific antigen (PSA)-only failure after local therapy (surgery, radiation therapy, brachytherapy, or cryotherapy)
  • Rising PSA despite androgen-deprivation therapy with castrate levels of testosterone (< 50 ng/dL)

    • Two successive rising PSA levels at least 1 week apart
    • PSA ≥ 5 ng/mL
  • Patients with a history of combined hormonal therapy must continue luteinizing-hormone releasing-hormone agonist treatment but must demonstrate rising PSA after anti-androgen withdrawal
  • No evidence of distant metastasis by bone scan and CT scan
  • No known brain metastases requiring active therapy

PATIENT CHARACTERISTICS:

  • ECOG performance status ≤ 3
  • Life expectancy ≥ 12 weeks
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT and/or SGPT ≤ 2.5 times ULN AND alkaline phosphatase normal OR alkaline phosphatase ≤ 4 times ULN AND SGOT and/or SGPT normal
  • Creatinine clearance ≥ 60 mL/min OR creatinine normal
  • Fertile patients must use effective contraception
  • None of the following conditions within the past 6 months:

    • Myocardial infarction
    • Severe or unstable angina
    • Symptomatic congestive heart failure
    • Cerebrovascular accident or transient ischemic attack
    • Coronary/peripheral artery bypass grafting
  • No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 28 days since prior radiotherapy
  • At least 28 days since prior investigational agents for treatment of prostate cancer
  • At least 4 weeks since prior flutamide
  • At least 6 weeks since prior bicalutamide
  • No other concurrent antineoplastic agents
  • No concurrent warfarin-related anticoagulants
  • No concurrent proton-pump inhibitor drugs for gastroesophageal reflux disease (e.g., rabeprazole, esomeprazole magnesium, lansoprazole, omeprazole, or pantoprazole sodium)
  • No concurrent micronutrient supplements or dietary soy products

    • One daily multivitamin allowed
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00305747
CDR0000462637
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-D-2979
WSU-0507002581
Yes
Not Provided
Not Provided
Elisabeth Heath, Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Study Chair: Elisabeth I. Heath, MD Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP