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3-AP in Treating Patients With Advanced Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
triapine
Sponsored by
Vion Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring recurrent prostate cancer, stage IV prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of hormone-refractory metastatic prostate cancer by one of the following methods: Measurable disease PSA level of at least 5 ng/mL with a positive bone scan Objective evidence of progressive metastatic disease in the past 3 months defined by any of the following: An increase in PSA value of at least 25% (minimum absolute increase of 5 ng/mL) on at least 2 successive occasions, at least 2 weeks apart A new symptomatic lesion on bone scan A new metastases not in bone Growth of existing non-bone measurable metastatic disease NOTE: An increase in pain or symptoms alone without other evidence of progression, or elevation of PSA or serum alkaline phosphatase alone without evidence of metastatic disease is not sufficient Prior bilateral orchiectomy or other primary hormonal treatment with evidence of treatment failure Patients with no prior bilateral orchiectomy must have a testosterone level less than 50 ng/mL and must continue leuteinizing hormone-releasing hormone therapy while on study No known active CNS metastases (excluding prior CNS metastases with currently stable disease after treatment ) PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy More than 3 months Hematopoietic WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic Bilirubin no greater than 2.0 mg/dL ALT/AST no greater than 5 times upper limit of normal Albumin greater than 2.5 g/dL Chronic hepatitis allowed Renal Creatinine no greater than 2.0 mg/dL Cardiovascular No myocardial infarction within the past 3 months No unstable angina No uncontrolled arrhythmias No uncontrolled congestive heart failure Pulmonary No dyspnea at rest Other Nutrition adequate (caloric intake considered adequate for maintenance of weight) Fertile patients must use effective contraception No prior or concurrent malignancies except for non-metastatic basal cell or squamous cell skin cancer or any stage I malignancy curatively resected more than 5 years ago No active uncontrolled infectious process No other life-threatening illness No peripheral neuropathy greater than grade 2 PRIOR CONCURRENT THERAPY: Biologic therapy At least 2 weeks since prior biologic therapy Chemotherapy At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No more than 1 prior chemotherapy regimen for metastatic disease Endocrine therapy See Disease Characteristics At least 4 weeks since other prior hormonal therapy including any of the following: Megestrol Finasteride Herbal products known to decrease PSA levels (e.g., saw palmetto and PC-SPES) Systemic corticosteroids 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 At least 8 weeks since prior radiopharmaceuticals (strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium) At least 4 weeks since prior radiotherapy and recovered Surgery See Disease Characteristics At least 3 weeks since prior major surgery and recovered Other No other concurrent investigational agents No other concurrent anticancer treatment

Sites / Locations

  • UCSF Comprehensive Cancer Center
  • H. Lee Moffitt Cancer Center and Research Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 5, 2003
Last Updated
November 5, 2013
Sponsor
Vion Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00054015
Brief Title
3-AP in Treating Patients With Advanced Prostate Cancer
Official Title
A Phase II Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) in Patients With Advanced Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2004
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vion Pharmaceuticals

4. Oversight

5. Study Description

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 3-AP in treating patients who have advanced prostate cancer that has been previously treated with hormone therapy.
Detailed Description
OBJECTIVES: Determine the response rate in patients with advanced hormone-refractory prostate cancer treated with 3-AP. Determine the toxic effects of this drug in these patients. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
recurrent prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
triapine

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of hormone-refractory metastatic prostate cancer by one of the following methods: Measurable disease PSA level of at least 5 ng/mL with a positive bone scan Objective evidence of progressive metastatic disease in the past 3 months defined by any of the following: An increase in PSA value of at least 25% (minimum absolute increase of 5 ng/mL) on at least 2 successive occasions, at least 2 weeks apart A new symptomatic lesion on bone scan A new metastases not in bone Growth of existing non-bone measurable metastatic disease NOTE: An increase in pain or symptoms alone without other evidence of progression, or elevation of PSA or serum alkaline phosphatase alone without evidence of metastatic disease is not sufficient Prior bilateral orchiectomy or other primary hormonal treatment with evidence of treatment failure Patients with no prior bilateral orchiectomy must have a testosterone level less than 50 ng/mL and must continue leuteinizing hormone-releasing hormone therapy while on study No known active CNS metastases (excluding prior CNS metastases with currently stable disease after treatment ) PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy More than 3 months Hematopoietic WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic Bilirubin no greater than 2.0 mg/dL ALT/AST no greater than 5 times upper limit of normal Albumin greater than 2.5 g/dL Chronic hepatitis allowed Renal Creatinine no greater than 2.0 mg/dL Cardiovascular No myocardial infarction within the past 3 months No unstable angina No uncontrolled arrhythmias No uncontrolled congestive heart failure Pulmonary No dyspnea at rest Other Nutrition adequate (caloric intake considered adequate for maintenance of weight) Fertile patients must use effective contraception No prior or concurrent malignancies except for non-metastatic basal cell or squamous cell skin cancer or any stage I malignancy curatively resected more than 5 years ago No active uncontrolled infectious process No other life-threatening illness No peripheral neuropathy greater than grade 2 PRIOR CONCURRENT THERAPY: Biologic therapy At least 2 weeks since prior biologic therapy Chemotherapy At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No more than 1 prior chemotherapy regimen for metastatic disease Endocrine therapy See Disease Characteristics At least 4 weeks since other prior hormonal therapy including any of the following: Megestrol Finasteride Herbal products known to decrease PSA levels (e.g., saw palmetto and PC-SPES) Systemic corticosteroids 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 At least 8 weeks since prior radiopharmaceuticals (strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium) At least 4 weeks since prior radiotherapy and recovered Surgery See Disease Characteristics At least 3 weeks since prior major surgery and recovered Other No other concurrent investigational agents No other concurrent anticancer treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Sznol, MD
Organizational Affiliation
Vion Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States

12. IPD Sharing Statement

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3-AP in Treating Patients With Advanced Prostate Cancer

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