Radioimmunotherapy in Prostate Cancer Using 177Lu-J591 Antibody

NCT00538668 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: 0602008378Repetitive dosing 177Lu-J591
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Prostate; Prostate Cancer; Prostate Ca

Outcome Measures

Primary Outcomes (4)

• Define the PK and dosimetry of 177Lu-J591

  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.

  Will be determined baesd on toxicity experienced by patients at each dose level.

• Determine the myelotoxicity of fractionated dose of 177Lu-J591

  Lab tests will be performed weekly.

• Define the preliminary efficacy (response rate) of 177Lu-J591

  PSA will be evaluated at baseline and weeks 6, 10 and 14. Scan will be perfoemed at baseline and week 14.

Secondary Outcomes (2)

• Monitor biochemical (PSA) and/or measurable disease response and duration.

  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.

  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

Study Arms (9)

1

EXPERIMENTAL

20 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart.

Drug: 117Lu-J591

2

EXPERIMENTAL

25 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart.

Drug: 117Lu-J591

3

EXPERIMENTAL

30 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart.

Drug: 117Lu-J591

4

EXPERIMENTAL

35 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart.

Drug: 117Lu-J591

5

EXPERIMENTAL

40 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart.

Drug: 117Lu-J591

6

EXPERIMENTAL

45 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart.

Drug: 117Lu-J591

7

EXPERIMENTAL

50 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart.

Drug: 117Lu-J591

8

EXPERIMENTAL

55 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart.

Drug: 117Lu-J591

9

EXPERIMENTAL

25 mCi/m2 of 177Lu-J591 will be given every 2 weeks.

Drug: 117Lu-J591

Interventions

117Lu-J591 DRUG

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.

1; 2; 3; 4; 5; 6; 7; 8; 9

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College-New York Presbyterian Hospital

New York, New York, 10021, United States

Location

Related Publications (2)

• Martiniova L, Zielinski RJ, Lin M, DePalatis L, Ravizzini GC. The Role of Radiolabeled Monoclonal Antibodies in Cancer Imaging and ADC Treatment. Cancer J. 2022 Nov-Dec 01;28(6):446-453. doi: 10.1097/PPO.0000000000000625.

  PMID: 36383907 DERIVED

• Vlachostergios PJ, Niaz MJ, Skafida M, Mosallaie SA, Thomas C, Christos PJ, Osborne JR, Molina AM, Nanus DM, Bander NH, Tagawa ST. Imaging expression of prostate-specific membrane antigen and response to PSMA-targeted beta-emitting radionuclide therapies in metastatic castration-resistant prostate cancer. Prostate. 2021 Apr;81(5):279-285. doi: 10.1002/pros.24104. Epub 2021 Jan 19.

  PMID: 33465252 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Scott Tagawa, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2007
• First Posted: October 3, 2007
• Study Start: August 1, 2007
• Primary Completion: October 1, 2015
• Study Completion: June 1, 2020
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)