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| ID | Type | Description | Link |
|---|---|---|---|
| VION-CLI-024 | |||
| MCC-13110 | |||
| MCC-IRB-100798 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| triapine | Drug |
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
No known active CNS metastases (excluding prior CNS metastases with currently stable disease after treatment )
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
See Disease Characteristics
At least 4 weeks since other prior hormonal therapy including any of the following:
At least 4 weeks since prior flutamide therapy (6 weeks for bicalutamide or nilutamide) with continued evidence of progressive disease documented by at least 1 PSA value after discontinuation
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Mario Sznol, MD | Vion Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Comprehensive Cancer Center | San Francisco | California | 94115 | United States | ||
| H. Lee Moffitt Cancer Center and Research Institute |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C078157 | 3-aminopyridine-2-carboxaldehyde thiosemicarbazone |
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| Tampa |
| Florida |
| 33612-9497 |
| United States |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |