Radioimmunotherapy in Prostate Cancer Using 177Lu-J591 Antibody
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.

      2. Perform imaging and pharmacokinetic (PK) studies with 177Lu-J591 in order to define the PK
      and dosimetry of 177Lu-J591 3. Determine the myelotoxicity of fractionated dose of 177Lu-J591
      4. Monitor biochemical (PSA) and/or measurable disease response and duration.

      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.
    

Intervention name(s): 117Lu-J591
Intervention type(s): Drug
Intervention description(s): 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.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prostate; Prostate Cancer; Prostate Ca