Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004149
Status:
COMPLETED
Last Update Posted:
2018-08-17
First Post:
1999-12-10
Brief Title:
Arsenic Trioxide in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Previous Hormone Therapy
Sponsor:
Albert Einstein College of Medicine
Organization:
Albert Einstein College of Medicine
Study Overview
Official Title:
A Phase II Trial of Arsenic Trioxide in Advanced Hormone-Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
OBJECTIVES
Determine the efficacy of arsenic trioxide in patients with metastatic stage IVA or IVB hormone-refractory prostate cancer
Determine the toxicity of this drug in this patient population
Assess in a preliminary manner the effect of this drug on pain control in these patients
Assess the potential value of serial quantitative prostate-specific antigen PSA and prostate-specific membrane antigen PSMA mRNA determinations in RNA from peripheral blood mononuclear cells as surrogate markers of disease response in patients treated with this drug
Assess the pharmacokinetics and pharmacodynamics of this drug in these patients
Assess the feasibility of using pretreatment bone marrow evaluation of PSA and PMSA mRNA levels and pi class glutathione S-transferase expression ie eliminate glutathione levels as potential correlates of disease response in patients treated with this drug
OUTLINE Patients receive arsenic trioxide IV over 2 hours on days 1-5 and 8-12 for one course Treatment continues as biweekly infusions for at least 14 additional weeks in the absence of disease progression unacceptable toxicity or excessive increase in serum prostate-specific antigen
Pain is assessed at baseline and then before each biweekly treatment
PROJECTED ACCRUAL A total of 17-37 patients will be accrued for this study within 12-24 months
Determine the efficacy of arsenic trioxide in patients with metastatic stage IVA or IVB hormone-refractory prostate cancer
Determine the toxicity of this drug in this patient population
Assess in a preliminary manner the effect of this drug on pain control in these patients
Assess the potential value of serial quantitative prostate-specific antigen PSA and prostate-specific membrane antigen PSMA mRNA determinations in RNA from peripheral blood mononuclear cells as surrogate markers of disease response in patients treated with this drug
Assess the pharmacokinetics and pharmacodynamics of this drug in these patients
Assess the feasibility of using pretreatment bone marrow evaluation of PSA and PMSA mRNA levels and pi class glutathione S-transferase expression ie eliminate glutathione levels as potential correlates of disease response in patients treated with this drug
OUTLINE Patients receive arsenic trioxide IV over 2 hours on days 1-5 and 8-12 for one course Treatment continues as biweekly infusions for at least 14 additional weeks in the absence of disease progression unacceptable toxicity or excessive increase in serum prostate-specific antigen
Pain is assessed at baseline and then before each biweekly treatment
PROJECTED ACCRUAL A total of 17-37 patients will be accrued for this study within 12-24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AECM-CCRC-9929 | None | None | None |
| AECM-1199908270 | None | None | None |
| NCI-T99-0077 | None | None | None |