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

NCT00305747 | Completed Phase 1 DMC

• 4 other identifiers: CDR0000462637P30CA022453WSU-D-2979WSU-0507002581
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer; adenocarcinoma of the prostate; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD), Dose limiting toxicity (DLT) & toxicities during study and for 30 days after

  During study and for 30 days after

Secondary Outcomes (4)

• Plasma pharmacokinetics as measured by occurrences of toxicity

  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

  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

  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

  At baseline, day 1 of each cycle and study termination

Study Arms (1)

BR-DIM

EXPERIMENTAL

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.

Drug: BR-DIM

Interventions

BR-DIM DRUG

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.

Also known as: oral microencapsulated diindolylmethane

BR-DIM

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Weisberg Cancer Treatment Center

Detroit, Michigan, 48334, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Elisabeth I. Heath, MD

  Barbara Ann Karmanos Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 21, 2006
• First Posted: March 22, 2006
• Study Start: August 1, 2005
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 15, 2014

Record last verified: 2014-01

Locations

US (2)