A Phase 1 interventional study of 117Lu-J591 in Prostate Cancer, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to male participants aged 21 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-03-19.
Sponsored by Weill Medical College of Cornell University · Phase 1, Interventional, and Treatment
The purpose of this study is to test the safety of the experimental drug, 177Lu-J591 and see what effects (good and bad) it has on your prostate cancer. Another purpose is to find the highest dose of the drug that can be given without causing severe side effects.
Study Design: We plan to perform a phase I dose-escalation study. The trial is designed to determine the cumulative MTD in a FDR in which 177Lu-J591 will be given in 2 doses, 2 weeks apart. The dose escalation will start at 20 mCi/m2 and escalate in increments of 5 mCi/m2 to 55 mCi/m2 in up to 8 cohorts.We plan to recruit a maximum of 68 subjects in this trial.
Specific Aims: 1. Determine the cumulative MTD of 177Lu-J591 in a 2 week dose-fractionation regimen.
Following the administration of 177Lu-J591 mAb on day 0, blood samples may be obtained at 10 min, 1, 2, 4 hrs, days 1, once during days 3-6, day 7 and 14. In addition, total body images may be obtained on day 0 at 1-4 hours after study treatment, day 1, once during days 3-6, days 7 and 14 using a gamma camera. (Amendment dated 15 July 2009: As investigators have gained ample information from the initial cohorts, PK and 177Lu-J591 imaging studies (other than the day 6-8 scan) will be considered optional.) Patients will be followed for a minimum of 12 weeks after the 2nd dose of 177Lu-J591 (total 14 weeks) or until toxicities resolve, disease progression or administration of alternative therapy for the patient¿s prostate cancer. Various clinical and laboratory evaluations will be performed during the first week and then every week until 12 weeks. These include, blood chemistries, CBCs, serum PSA levels, etc. If the patient¿s disease is stable or responding at 12 weeks after his last dose, he will continue to be followed until progression of disease. During the long-term follow-up, the patient¿s PSA will be monitored at least every 6 weeks and CT/bone scans will be evaluated at least every 18 weeks until disease progression.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 55 is close to the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.
Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.
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Progressive, castrate metastatic carcinoma of the prostate defined by presence of metastatic disease on imaging and:
rising PSA
Exclusion Criteria
20 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart.
Drug: 117Lu-J591
25 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart.
Drug: 117Lu-J591
30 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart.
Drug: 117Lu-J591
35 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart.
Drug: 117Lu-J591
40 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart.
Drug: 117Lu-J591
45 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart.
Drug: 117Lu-J591
50 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart.
Drug: 117Lu-J591
55 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart.
Drug: 117Lu-J591
25 mCi/m2 of 177Lu-J591 will be given every 2 weeks.
Drug: 117Lu-J591
There will be 9 groups of patients. The first group will receive 20 units of test drug and the 9th group will receive 55 units of the test drug. The exact dose of the test drug will depend upon how many patients have been included in this protocol at the time of patient enrollment. Patients will receive 20-55 units (or millicuries) of radioactivity depending upon patient specific height and weight. The assignment of each patient for a specific dose level is purely based on the sequence of recruitment basis and does not depend on the clinical status of the patient.
Define the PK and dosimetry of 177Lu-J591
Time frame: Perform imaging and pharmacokinetic (PK) sampling during the first two weeks of treatment.
Determine the cumulative maximum tolerated dose of 177Lu-J591 in a 2 week dose-fractionation regimen.
Time frame: Will be determined baesd on toxicity experienced by patients at each dose level.
Determine the myelotoxicity of fractionated dose of 177Lu-J591
Time frame: Lab tests will be performed weekly.
Define the preliminary efficacy (response rate) of 177Lu-J591
Time frame: PSA will be evaluated at baseline and weeks 6, 10 and 14. Scan will be perfoemed at baseline and week 14.
Monitor biochemical (PSA) and/or measurable disease response and duration.
Time frame: PSA will be evaluated at baseline and weeks 6, 10 and 14. Scan will be perfoemed at baseline and week 14.
Estimate radiation dosimetry of 177Lu-J591 and correlate toxicity with radiation dosimetry.
Time frame: Total body images will be obtained on day 0 at 1-4 hours after treatment, day 1, once during days 3-6, days 7 and 14
Plan to share: No
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Weill Medical College of Cornell University