Radioimmunotherapy in Prostate Cancer Using 177Lu-J591 Antibody

Completed · Phase 1

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID: NCT00538668
Run by: Weill Medical College of Cornell University
People needed: 55
Starts: 2007-08-01
Expected to finish: 2020-06-01
Last updated by the study team: 2021-03-19

Who can join

Age: 21 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

Histologic diagnosis (recent or remote) of prostate adenocarcinoma
Progressive, castrate metastatic carcinoma of the prostate defined by presence of metastatic disease on imaging and:
progressive tumor lesions on CT or MRI and/or
new osseus lesions on bone scan and/or
rising PSA
Rising PSA on 3 serial determinations over a period of greater than 2 weeks. An increase in PSA must be determined by two separate measurements taken at least one week apart and confirmed by a third and if necessary, a fourth measurement. If the third measurement is not greater than the second, then a fourth measurement must be taken. The fourth measurement must be greater than the second measurement for the patients to be eligible for enrollment in the study. The minimum final PSA must be > 2.
For subjects who have not undergone surgical orchiectomy, LHRH agonist or antagonist therapy must me maintained for the duration of this study
Platelet count > 150,000/mm3
Absolute neutrophil count (ANC) ≥ 2,000/mm3
Normal coagulation profile (defined as PT or INR and PTT < 1.3x ULN), unless on a stable anticoagulation regimen
Hematocrit > 27% or Hemoglobin > 9 g/dL without blood transfusion dependency
Patients of child bearing potential must agree to use an effective method of contraception
Patient must have progressed following discontinuation of anti-androgen therapy, if received
Serum testosterone < 50 ng/ml

You may not qualify if…

Prior corticosteroids and/or adrenal hormone inhibitors within 4 weeks of treatment, except for low dose maintenance prednisone or hydrocortisone (i.e. for adrenal insufficienty) on a stable dose at the investigator's discretion
Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment.
Prior radiation therapy encompassing >25% of expected red marrow distribution.
Prior treatment with 89Strontium (Metastron®) or 153Samarium (Quadramet®)
CNS metastasis
History of seizure and/or stroke within past 6 months
Known history of HIV
Serum creatinine > 2x ULN
AST > 2x ULN
Bilirubin (total) > 1.5x ULN; subjects with Gilbert's syndrome will be allowed if direct bilirubin is within institutional normal limits
Serious active infection (as assessed by investigator)
Active angina pectoris or NY Heart Association Class III-IV
ECOG Performance Status > 2
Life expectancy < 6 months
Age < 21 y.o
Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study
Prior treatment with monoclonal Ab J591 labeled with therapeutic doses of 177Lu or 90Y
Other investigational therapy within 4 weeks of treatment
Inability to understand and the willingness to sign a written informed consent document or to follow investigational procedures in the opinion of the investigator

Where it is running

Weill Cornell Medical College-New York Presbyterian Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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