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A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer Clinical research trials and A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer health trials occur in hundreds of cities 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 typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer. A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer  A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer
A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer
For Condition: Prostatic Neoplasms
Status: Recruiting
Sponsor(s): Millennium Pharmaceuticals ,
Synopsis: The purpose of the study is to determine the highest dose of MLN2704 that can be given multiple times safely to patients with prostate cancer, and to identify any side effects associated with taking the drug. This study will also evaluate how MLN2704 is taken up, broken down and eliminated by the body.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Male
Protocol Entry Criteria: Inclusion Criteria: 1. Histologic or cytologic diagnosis (recent or remote) of prostate adenocarcinoma 2. Radiographic evidence (recent or remote) of metastatic prostate adenocarcinoma 3. 18 years of age or older 4. Progressive prostate cancer as defined by the presence of one or more of the following despite castrate levels of testosterone (testosterone <50 ng/dL): • Progressive tumor lesions (changes in the size of lymph nodes or parenchymal masses on physical examination or X-ray and CT scan or MRI) • Progressive bone metastasis (presence of new lesion(s) on a bone scan) • Progressive PSA levels (as defined in Section 3.6.1) 5. Subjects who have received an anti-androgen must have shown progression of disease following discontinuation of the anti-androgen 6. Subjects must remain on LHRH analog therapy for the duration of the trial unless surgically castrate 7. Agree to use an effective barrier method of contraception. Exclusion criteria: 1. Testosterone >50 ng/dL 2. Use of corticosteroids and/or adrenal hormone inhibitors within 4 weeks of dosing 3. Use of PC-SPES within 4 weeks of dosing 4. Prior cytotoxic chemotherapy and/or radiation therapy within 6 weeks of dosing 5. Use of anti-androgen therapy (eg, flutamide, bicalutamide, nilutamide) within 6 weeks of dosing 6. Prior monoclonal antibody administration, including Prostascint® 7. Peripheral neuropathy of Grade 2, as defined by the NCI Common Toxicity Criteria for Adverse Events (NCI CTCAE) 8. History of CNS metastasis, including incompletely treated epidural disease 9. History of Hepatitis B or C 10. History of seizure disorder requiring active treatment and/or stroke 11. History of HIV infection 12. Platelet count <100,000/mm3 13. Absolute neutrophil count (ANC) <1,500/mm3 14. Hematocrit <27 percent 15. Abnormal coagulation profile (elevated PT, and/or INR, PTT) 16. Serum creatinine >2.0 mg/dL, or creatinine clearance <60 mL/min if serum creatinine 2.0 mg/dL 17. AST or ALT >1.5 x ULN 18. Bilirubin (total) >1.25 x ULN 19. Serum calcium >12.5 mg/dL 20. Active serious infection not controlled by antibiotics 21. Active angina pectoris or NY Heart Association Class III-IV heart disease 22. Karnofsky Performance Status <60% 23. Life expectancy <6 months 24. Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems that might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
Total Enrollment: 46
Location and Contact Information:
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting
Weill Medical College of Cornell University/ New York Presbyterian Hospital *Recruiting*
New York City, New York, 10021
United States
Recruiting
Additional Information:
Study ID Numbers: M59102-051;
Study Start Date: October 2003
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070837
Other Prostatic Neoplasms Studies:
1. Safety and pharmacokinetics of orally administered gallium maltolate in various refractory malignancies.
2. Comparison PSA Vaccine Alone or Vaccine with Docetaxel for Treating Prostate Cancer
3. Magnetic Resonance-Guided High-Dose Brachytherapy (Short-Range Radiation Therapy) for Prostate Cancer
4. A Phase I Study of Recombinant Vaccinia Virus that Expresses Prostate Specific Antigen in Adult Patients with Adenocarcinoma of the Prostate
5. Study of Prostate Cancer in Black and White U.S. Veterans
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A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer
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