NCT00004149

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have stage IV prostate cancer that has not responded to hormone therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Timeline
Completed

Started Sep 1999

Geographic Reach
1 country

3 active sites

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

September 1, 1999

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

3.9 years

First QC Date

December 10, 1999

Last Update Submit

August 15, 2018

Conditions

Prostate Cancer

Keywords

stage IV prostate cancerrecurrent prostate cancer

Interventions

arsenic trioxideDRUG

Eligibility Criteria

AgeUp to 120 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • No significant active infectious disease
  • No grade 2 or greater peripheral neuropathy
  • No other debilitating acute or chronic co-morbid medical, neurological, or psychiatric condition that would preclude study compliance
  • No concurrent amphotericin B or other agent that prevents restoration of potassium or magnesium to normal levels and/or correction of QT interval to under 500 milliseconds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mount Sinai Medical Center, NY

New York, New York, 10029, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Albert Einstein Clinical Cancer Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

  • Gallagher RE, Ferrari A, Kaubisch A, et al.: Arsenic trioxide (ATO) in metastatic hormone-refractory prostate cancer (HRPC): results of phase II trial T99-0077. [Abstract] J Clin Oncol 22 (Suppl 14): A-4638, 2004.

    RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • Robert E. Gallagher, MD

    Albert Einstein College of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 1999

First Posted

January 27, 2003

Study Start

September 1, 1999

Primary Completion

August 1, 2003

Study Completion

August 1, 2003

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations

US(3)