3-AP in Treating Patients With Advanced Prostate Cancer

NCT00054015 | Completed Phase 2

• 4 other identifiers: CDR0000269675VION-CLI-024MCC-13110MCC-IRB-100798
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer; stage IV prostate cancer

Interventions

triapine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vion Pharmaceuticals: lead

Study Sites (2)

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

3-aminopyridine-2-carboxaldehyde thiosemicarbazone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Mario Sznol, MD

  Vion Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 5, 2003
• First Posted: February 6, 2003
• Study Start: December 1, 2002
• Study Completion: January 1, 2008
• Last Updated: November 6, 2013

Record last verified: 2004-04

Locations

US (2)