The purpose of this study is to find out how effective 177Lu -J591 is in the treatment of patients with metastatic, androgen-independent prostate cancer.
To determine the clinical activity of 177Lu -J591 for the treatment of patients with metastatic, androgen-independent prostate cancer. Patients will receive a single dose of J591 (total antibody of 20 mg) consisting of antibody chelated with 177Lu at a dose of 65 or 70 mCi/m2 with a specific activity of 12-15 mCi/mg plus non-radiolabeled antibody.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
Weill Medcial College of Cornell University
New York, New York, United States
Define the PSA Response Rate.
PSA response rate corresponds to change form baseline in PSA at any of the time points specified.
Time frame: At baseline, Day 1, 29, 43, 57, 85, week 18, week 24 & every 12 weeks
Define the Measurable Disease Response Rate.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study
Time frame: Disease will be assessed at baseline and day 85.
Define the Duration of Biochemical PSA and/or Measurable Disease Response.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions, Complete Response (CR) = Disappearance of all target lesions, Partial Response (PR) = A \</=30% decrease in the sum of the longest diameter of target lesions, taking as reference the Baseline sum longest diameter, Stable Disease (SD) = Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started, Progressive Disease (PD) = A \>/=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions
Time frame: At baseline, and up to death
Define the Toxicity of 177Lu-J591 Given as Single Dose.
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Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL\*. Grade 3 Severe or medically significant but not immediately life-threatening hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL\*\*. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Time frame: From baseline until end of treatment phase (12 weeks)
Define the Incidence of Human Anti-J591 Antibody (HAHA) Response.
Time frame: HAHA samples will be drawn at baseline and Day 85.
Number of Participants With Hematological Toxicity Relative to Bone Marrow Involvement (Bone Scan Index).
Bone scan score determined for each patient and related to the degree of hematological toxicity quantified by % decline of nadir platelet count relative to baseline count.
Time frame: Bone scan will be performed at baseline and Day 85.
Assess the Survival Rate of Patients Following Treatment.
Time frame: From baseline through study completion
Number of Participants With Targeting of 177Lu-J591 to Known Tumor Sites.
Time frame: Scans will be performed between day 6 and 8.