Expired Study
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New York, New York 10021


Purpose:

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 trial to study the effect of MLN2704 on the body in treating patients who have progressive metastatic prostate cancer.


Study summary:

OBJECTIVES: - Determine the dose-limiting toxicity and maximum tolerated dose of MLN2704 immunoconjugate in patients with progressive metastatic androgen-independent prostate cancer. - Determine the pharmacokinetics of this drug in these patients. - Determine the prostate-specific antigen and disease response in patients treated with this drug. - Determine the anti-MLN591 antibody and anti-MLN2704 antibody response to this drug in these patients. OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients receive MLN2704 IV over 2.5 hours on day 1. Treatment repeats every 6-8 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity. Patients with responsive disease after 3 doses of therapy may receive additional therapy as above at the investigator's discretion. 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. Patients are followed every 3 months until disease progression. PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study within 1 year.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed prostate adenocarcinoma - Metastatic disease - Progressive disease by physical exam, imaging studies, and/or rising prostate-specific antigen (PSA) levels defined by at least 1 of the following criteria*: - 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 PSA levels despite castrate levels of testosterone - PSA at least 5 ng/mL - Progression of disease demonstrated after completion of antiandrogen therapy NOTE: *Patients whose sole manifestation of progressive disease is an increase in disease-related symptoms are not eligible - Measurable or evaluable disease - Failed prior hormonal therapy (including antiandrogen withdrawal therapy) - No history of CNS metastasis (including epidural disease) PATIENT CHARACTERISTICS: Age - Not specified Performance status - Karnofsky 60-100% Life expectancy - At least 6 months Hematopoietic - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count greater than 100,000/mm^3 - Hematocrit greater than 30% - No serious hematologic illness that would preclude study completion or interfere with determination of causality of study adverse events Hepatic - Bilirubin no greater than upper limit of normal (ULN) - AST or ALT no greater than 1.5 times ULN - PTT normal - PT and INR normal - No serious hepatic illness that would preclude study completion or interfere with determination of causality of study adverse events Renal - Creatinine no greater than 2.0 mg/dL OR - Creatinine clearance at least 60 mL/min - Calcium less than 12.5 mg/dL - No serious renal illness that would preclude study completion or interfere with determination of causality of study adverse events Cardiovascular - No history of stroke - No active angina pectoris - No New York Heart Association class III or IV heart disease - No serious cardiac illness that would preclude study completion or interfere with determination of causality of study adverse events Pulmonary - No serious respiratory illness that would preclude study completion or interfere with determination of causality of study adverse events Other - Fertile patients must use effective barrier contraception - HIV negative - No history of seizure disorder requiring active treatment - No serious CNS illness that would preclude study completion or interfere with determination of causality of study adverse events - No grade 2 or greater peripheral neuropathy - No active serious infection not controlled by antibiotics - No other serious illness that would preclude study completion or interfere with determination of causality of study adverse events PRIOR CONCURRENT THERAPY: Biologic therapy - No prior monoclonal antibody therapy (including Prostacint®) - No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or other white cell colony-stimulating factors, except for febrile neutropenia - No concurrent interleukin-11 for platelet count support Chemotherapy - More than 6 weeks since prior cytotoxic chemotherapy Endocrine therapy - See Disease Characteristics - More than 4 weeks since prior corticosteroids and/or adrenal hormone inhibitors - More than 6 weeks since prior antiandrogen therapy (e.g., flutamide, bicalutamide, or nilutamide) - No prior finasteride (Proscar® or Propecia®) - Luteinizing hormone-releasing hormone (LHRH) analog therapy allowed if 1 of the following circumstances exists: - If patient is currently receiving LHRH analog therapy, therapy must be maintained for study duration - If patient discontinued LHRH analog therapy prior to study entry, therapy must be discontinued at least 10 weeks prior to study entry for 1-month depot preparations, 24 weeks for 3-month depot preparations, or 32 weeks for 4-month depot preparations Radiotherapy - More than 6 weeks since prior radiotherapy Surgery - Not specified Other - More than 4 weeks since prior PC-SPES - No other concurrent medication for platelet count support


NCT ID:

NCT00058409


Primary Contact:

Study Chair
Howard I. Scher, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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