NCT00002677

Brief Summary

Phase I trial to study the effectiveness of tributyrin in treating patients with refractory stage IV prostate cancer or other solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 prostate-cancer

Timeline
Completed

Started Aug 1995

Longer than P75 for phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1995

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

May 11, 2004

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

7.6 years

First QC Date

November 1, 1999

Last Update Submit

October 31, 2019

Conditions

Prostate CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage IV prostate cancerrecurrent prostate cancerunspecified adult solid tumor, protocol specific

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oral tributyrin every 8 hours for 3 weeks. Treatment continues every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease may receive additional courses at the discretion of the protocol chairperson. Cohorts of 3-6 patients receive escalating doses of tributyrin 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.

Drug: chemotherapyDrug: tributyrin

Interventions

chemotherapyDRUG
Arm I
tributyrinDRUG
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven prostate cancer or other solid tumor that is refractory to standard treatment or for which no standard therapy exists * Patients with prostate cancer must meet the following conditions: * Stage D2 disease * Disease progression after orchiectomy or treatment with leuprolide or flutamide * If no prior orchiectomy, must continue leuprolide or other antiandrogen throughout study * No CNS neoplasms or brain metastases PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: ECOG 0-2 * Life expectancy: More than 3 months * WBC at least 3,000/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 9 g/dL * Bilirubin no greater than 1.5 mg/dL * AST and ALT no greater than 1.5 times normal * Creatinine no greater than 1.5 mg/dL OR creatinine clearance greater than 50 mL/min * No concurrent medical or psychiatric condition that would preclude study * Able to swallow numerous capsules * Willing to participate in pharmacokinetic studies * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * At least 4 weeks since prior chemotherapy (more than 8 weeks since prior carmustine, mitomycin, or other drugs with delayed toxic effects) and recovered * No prior suramin * At least 4 weeks since prior flutamide * No concurrent hydrocortisone or other steroids * At least 4 weeks since prior radiotherapy and recovered * No concurrent palliative radiotherapy

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

Sponsors & Collaborators

Study Sites (1)

Marlene & Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Drug Therapytributyrin

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • David A. Van Echo, MD

    University of Maryland Greenebaum Cancer Center

    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
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 11, 2004

Study Start

August 1, 1995

Primary Completion

March 1, 2003

Study Completion

March 1, 2003

Last Updated

November 4, 2019

Record last verified: 2019-10

Locations

US(1)