|
3-AP in Treating Patients With Advanced Prostate Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about 3-AP in Treating Patients With Advanced Prostate Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. 3-AP in Treating Patients With Advanced Prostate Cancer Clinical research trials and 3-AP in Treating Patients With Advanced Prostate Cancer medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like 3-AP in Treating Patients With Advanced Prostate Cancer. 3-AP in Treating Patients With Advanced Prostate Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a 3-AP in Treating Patients With Advanced Prostate Cancer clinical trial. Test subjects typically obtain the finest healthcare available for their 3-AP in Treating Patients With Advanced Prostate Cancer condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "3" Clinical Trials Conditions > 3-AP in Treating Patients With Advanced Prostate Cancer  3-AP in Treating Patients With Advanced Prostate Cancer
3-AP in Treating Patients With Advanced Prostate Cancer
For Condition: stage 4 prostate cancer,recurrent prostate cancer
Status: Recruiting
Sponsor(s): Vion Pharmaceuticals ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarioSznol, Study Chair, Vion Pharmaceuticals
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Jonathan Rosenberg 415-719-1142
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Mayer Fishman 813-979-3982
Additional Information:
Study ID Numbers: CDR0000269675; MCC-IRB-100798,MCC-13110,VION-CLI-024
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054015
Other Recurrent Prostate Cancer Studies:
1. Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer
2. Low, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer
3. Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer
4. Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer
5. Vaccine Therapy and Sargramostim Compared With Empty Vector Control in Treating Patients With Metastatic Androgen-Independent Prostate Cancer
Related Studies:
Other recurrent prostate cancer Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
3-AP in Treating Patients With Advanced Prostate Cancer
|
|
|
|
|
|
|
|
