Prostate CancerPhase 1NCT00538668
Radioimmunotherapy in Prostate Cancer Using 177Lu-J591 Antibody
A Phase 1 study testing 117Lu-J591 in people with Prostate Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 117Lu-J591
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jun 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, 10021
About this study
Official title: Radioimmunotherapy Phase I Dose-Escalation Studies in Prostate Cancer Using 177Lu-J591 Antibody: Dose Fractionation Regimen
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.
Read the 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.
- 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.
- Conditions
- Prostate Cancer
- Being tested
- 117Lu-J591
- Keywords
- Prostate, Prostate Cancer, Prostate Ca
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
117Lu-J591Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 20 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart. Receives: Drug: 117Lu-J591 |
| 2 | Experimental | 25 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart. Receives: Drug: 117Lu-J591 |
| 3 | Experimental | 30 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart. Receives: Drug: 117Lu-J591 |
| 4 | Experimental | 35 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart. Receives: Drug: 117Lu-J591 |
| 5 | Experimental | 40 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart. Receives: Drug: 117Lu-J591 |
| 6 | Experimental | 45 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart. Receives: Drug: 117Lu-J591 |
| 7 | Experimental | 50 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart. Receives: Drug: 117Lu-J591 |
| 8 | Experimental | 55 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart. Receives: Drug: 117Lu-J591 |
| 9 | Experimental | 25 mCi/m2 of 177Lu-J591 will be given every 2 weeks. Receives: Drug: 117Lu-J591 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define the PK and dosimetry of 177Lu-J591
Measured: 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.
Measured: Will be determined baesd on toxicity experienced by patients at each dose level.
Determine the myelotoxicity of fractionated dose of 177Lu-J591
Measured: Lab tests will be performed weekly.
Define the preliminary efficacy (response rate) of 177Lu-J591
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2007 (estimated)
- Study startAug 2007
- Primary completionOct 2015
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Tagawa, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538668
- Sponsor's protocol ID
- 0602008378
- Other IDs
- Repetitive dosing 177Lu-J591
- Status last verified
- Mar 2021
- First submitted
- 2 Oct 2007
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36383907Vlachostergios 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.
PubMed 33465252
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radioimmunotherapy Phase I Dose-Escalation Studies in Prostate Cancer Using 177Lu-J591 Antibody: Dose Fractionation Regimen
- ClinicalTrials.gov ID
- NCT00538668
- Acronym / sponsor ID
- 0602008378
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Prostate Cancer, Prostate Ca
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Aug 2007 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 3 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 117Lu-J59120 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart. |
| 2 | Experimental | Drug: 117Lu-J59125 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart. |
| 3 | Experimental | Drug: 117Lu-J59130 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart. |
| 4 | Experimental | Drug: 117Lu-J59135 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart. |
| 5 | Experimental | Drug: 117Lu-J59140 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart. |
| 6 | Experimental | Drug: 117Lu-J59145 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart. |
| 7 | Experimental | Drug: 117Lu-J59150 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart. |
| 8 | Experimental | Drug: 117Lu-J59155 mCi/m2 of 177Lu-J591 will be given in 2 doses, 2 weeks apart. |
| 9 | Experimental | Drug: 117Lu-J59125 mCi/m2 of 177Lu-J591 will be given every 2 weeks. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologic diagnosis (recent or remote) of prostate adenocarcinoma
- Progressive, castrate metastatic carcinoma of the prostate defined by presence of metastatic disease on imaging and:
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 117Lu-J591There 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. | Drug | 1, 2, 3, 4, 5, 6, 7, 8, 9 |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Derived from this study: PubMed 36383907Martiniova 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.
- Derived from this study: PubMed 33465252Vlachostergios 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Tagawa, M.D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 117Lu-J591 in people with Prostate Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define the PK and dosimetry of 177Lu-J591 (time frame: Perform imaging and pharmacokinetic (PK) sampling during the first two weeks of treatment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00538668, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.