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| Sponsor: | Vion Pharmaceuticals |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00054015 |
Purpose
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 3-AP in treating patients who have advanced prostate cancer that has been previously treated with hormone therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: triapine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) in Patients With Advanced Prostate Cancer |
| Study Start Date: | December 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive 3-AP IV over 2 hours on days 1-4. Treatment repeats every 2 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2-3 months for up to 1 year.
PROJECTED ACCRUAL: Approximately 13-27 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of hormone-refractory metastatic prostate cancer by one of the following methods:
Objective evidence of progressive metastatic disease in the past 3 months defined by any of the following:
Prior bilateral orchiectomy or other primary hormonal treatment with evidence of treatment failure
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
At least 4 weeks since other prior hormonal therapy including any of the following:
Radiotherapy
Surgery
Other
Contacts and Locations| United States, California | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612-9497 | |
| Study Chair: | Mario Sznol, MD | Vion Pharmaceuticals |
More Information
| Study ID Numbers: | CDR0000269675, VION-CLI-024, MCC-13110, MCC-IRB-100798 |
| Study First Received: | February 5, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00054015 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent prostate cancer stage IV prostate cancer |
|
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |