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MLN2704 in Treating Patients With Progressive Metastatic Prostate Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about MLN2704 in Treating Patients With Progressive Metastatic Prostate Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. MLN2704 in Treating Patients With Progressive Metastatic Prostate Cancer Clinical research trials and MLN2704 in Treating Patients With Progressive Metastatic Prostate Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including MLN2704 in Treating Patients With Progressive Metastatic Prostate Cancer. MLN2704 in Treating Patients With Progressive Metastatic Prostate Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a MLN2704 in Treating Patients With Progressive Metastatic Prostate Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their MLN2704 in Treating Patients With Progressive Metastatic Prostate Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > MLN2704 in Treating Patients With Progressive Metastatic Prostate Cancer  MLN2704 in Treating Patients With Progressive Metastatic Prostate Cancer
MLN2704 in Treating Patients With Progressive Metastatic Prostate Cancer
For Condition: recurrent prostate cancer,adenocarcinoma of the prostate,stage 4 prostate cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies such as MLN2704 can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of MLN2704 in treating patients who have progressivemetastaticprostate cancer.
Details: OBJECTIVES: Primary - Determine the dose-limiting toxicity and maximum tolerated dose of MLN2704 (administered in two different dosing schedules) in patients with progressive metastatic androgen-independent prostate cancer. Secondary - Determine the pharmacokinetics of this drug in these patients. - Determine the anti-MLN591 antibody and anti-MLN2704 antibody response in patients treated with this drug. - Determine the disease response in patients treated with this drug, through changes in either prostate-specific antigen levels or anatomically measurable disease. OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients are assigned to 1 of 2 dosing schedules. - Schedule 1: Patients receive MLN2704 IV once every 2 weeks for 12 weeks (6 total doses) in the absence of disease progression or unacceptable toxicity. After receiving 6 doses, patients with at least a 50% decline in prostate-specific antigen (PSA) levels or a partial response (PR) or complete response (CR) may receive an additional 6 weeks of therapy (3 additional doses). - Schedule 2: Patients receive MLN2704 IV once a week for 12 weeks (12 total doses) in the absence of disease progression or unacceptable toxicity. After receiving 12 doses, patients with at least a 50% decline in PSA levels or a PR or CR may receive an additional 6 weeks of therapy (6 additional doses). In both schedules, cohorts of 3-6 patients receive escalating doses of MLN2704 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. - Phase II: Once the MTD is determined, a total of 14 patients receive MLN2704 at the MTD as in phase I. Patients are followed at 15 days, 30 days, and then every 3 months until disease progression. PROJECTED ACCRUAL: Approximately 46 patients (23 per dosing schedule) will be accrued for this study within 8 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed prostate adenocarcinoma - Metastatic disease by radiography - Progressive disease*, defined by the presence of at least 1 of the following despite castrate levels of testosterone (less than 50 ng/dL): - Progressive tumor lesions (changes in the size of lymph nodes or parenchymal masses on physical exam or x-ray and CT scan or MRI) - Progressive bone metastases (presence of new lesion[s] on a bone scan) - Progressive prostate-specific antigen (PSA) levels - PSA at least 5 ng/mL NOTE: *If previously treated with antiandrogen therapy (e.g., flutamide, bicalutamide, or nilutamide), disease progression must be demonstrated after discontinuation of antiandrogen therapy - Must remain on luteinizing hormone-releasing hormone analog therapy during study treatment unless surgically castrate - No history of CNS metastasis, including incompletely treated epidural disease PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - At least 6 months Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hematocrit at least 27% - No other serious illness involving the hematologic system that would preclude study participation Hepatic - Bilirubin no greater than 1.25 times upper limit of normal (ULN) - AST or ALT no greater than 1.5 times ULN - PT normal - INR normal - PTT normal - No history of hepatitis B or C - No other serious illness involving the hepatic system that would preclude study participation Renal - Creatinine no greater than 2.0 mg/dL OR - Creatinine clearance at least 60 mL/min - Calcium no greater than 12.5 mg/dL - No other serious illness involving the renal system that would preclude study participation Cardiovascular - No history of stroke - No active angina pectoris - No New York Heart Association class III or IV heart disease - No other serious illness involving the cardiac system that would preclude study participation Pulmonary - No other serious illness involving the respiratory system that would preclude study participation Other - Fertile patients must use effective barrier contraception - HIV negative - No grade 2 or greater peripheral neuropathy - No history of seizure disorder requiring active treatment - No active serious infection not controlled by antibiotics - No other serious illness involving the CNS system that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No prior or concurrent monoclonal antibody therapy, including Prostascint® - No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or other white blood cell colony-stimulating factors, in the absence of febrile neutropenia - No concurrent medication to support platelet count (e.g., interleukin-11 [ Neumega®]) Chemotherapy - More than 6 weeks since prior cytotoxic chemotherapy - No concurrent cytotoxic chemotherapy Endocrine therapy - See Disease Characteristics - More than 6 weeks since prior antiandrogen therapy - More than 4 weeks since prior corticosteroids and/or adrenal hormone inhibitors - No concurrent corticosteroids and/or adrenal hormone inhibitors - No concurrent antiandrogen therapy - No concurrent finasteride Radiotherapy - More than 6 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - More than 4 weeks since prior PC-SPES - No concurrent PC-SPES - No concurrent aspirin and/or nonsteroidal anti-inflammatory agents when platelet count is less than 50,000/mm^3
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HowardScher, Principal Investigator, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Howard Scher 646-422-4323
Additional Information:
Study ID Numbers: CDR0000343623; MSKCC-03097,MILLENNIUM-M59102-051
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074347
Other Adenocarcinoma Of The Prostate Studies:
1. Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer
2. Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy
3. Antineoplaston Therapy in Treating Patients With Metastatic Prostate Cancer
4. Combination Chemotherapy Plus Bevacizumab in Treating Patients With Metastatic Prostate Cancer
5. BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
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MLN2704 in Treating Patients With Progressive Metastatic Prostate Cancer
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