Kidney CancerPhase 1NCT00967577
177Lu-J591 Antibody in Patients With Nonprostate Metastatic Solid Tumors
A Phase 1 study testing 177Lu-J591 in people with Kidney Cancer and Head and Neck Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate changes in tumor blood flow and disease response to the investigation agent, 177Lu-J591. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer, Head and Neck Cancer, Breast Cancer
- What is being tested?
- 177Lu-J591
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to 31 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically, or cytologically documented, advanced stage, malignant adult solid tumors (except prostate cancer) that are refractory to, or recurrent from, standard therapy or for which no curative standard therapy exists. This will include, but is not limited to patients with cancers of the kidney, urothelium, head and neck, breast, non-small cell lung, colorectal, pancreas, ovary, esophagus and gliomas.
- Metastatic or recurrent solid tumor malignancy defined by abnormal CT, MRI, PET scan, CXR and/or bone scan
- Progressive disease manifest by: Development of new lesions or an increase in size of preexisting lesions on imaging study or by physical examination.
- Subjects must have recovered from the acute toxicities of any prior therapy, and not received chemotherapy, radiation therapy or other investigational anticancer therapeutic drug for at least 4 weeks prior to J591 administration in this trial
- All subjects must have archived or current tissue (from a primary or metastatic focus) available for PSMA determination.
- Subjects on bisphosphonate therapy or denosumab must be on a stable dose and must have started therapy > 4 weeks prior to protocol therapy.
- Subjects will be informed as to the potential risk of procreation while participating on this trial and will be advised to use effective contraception during the entire study period. Females of child-bearing potential must have a negative pregnancy test.
Who cannot join
- Use of platelet transfusions within 4 weeks of treatment.
- Use of hematopoietic growth factors within 4 weeks of treatment.
- Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment.
- Prior radiation therapy encompassing >25% of skeleton.
- Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®)
- Platelet count <150,000/mm3 or history of platelet count abnormality or dysfunction.
Show all 23Show fewer
- Absolute neutrophil count (ANC) <2,000/mm3
- Hematocrit <30 percent or Hemoglobin < 10 g/dL
- Abnormal coagulation profile (PT or INR, PTT) > 1.3x upper limit of normal (ULN) unless on therapeutic anticoagulation
- Serum creatinine > 2x ULN
- AST (SGOT) >2.5x ULN
- Bilirubin (total) >1.5x ULN; subjects with known Gilbert's syndrome are eligible if direct bilirubin is within institutional normal limits
- Active serious infection
- Active angina pectoris or NY Heart Association Class III-IV
- ECOG Performance Status > 2
- Deep vein thrombosis and/or pulmonary embolus within 1 month of enrollment.
- 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 investigational therapy (medications or devices) within 4 weeks of treatment.
- Known history of HIV.
- Known leukemia or myelodysplastic syndrome
- Prior allergic reaction to Gadolinium contrast.
- Life expectancy < 3 months
- If alternative treatments are available, metastatic disease should not be progressing so as to anticipate the necessity of urgent treatment within 12 weeks of enrollment based on clinical assessment of the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10021
About this study
Official title: 177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Nonprostate Metastatic Solid Tumors: A Pilot Study
The purpose of this study is to evaluate changes in tumor blood flow and disease response to the investigation agent, 177Lu-J591.
Read the detailed description
177Lu-J591 is made up of two compounds called J591 and 177Lutetium (177Lu) that are joined together by a connecting molecule called "DOTA". J591 is a monoclonal antibody, or a type of protein. 177Lu is a radioactive molecule that is being tested for the possible treatment of cancer when joined to monoclonal antibodies. J591 attaches to a protein called prostate specific membrane antigen (PSMA) found in the body. PSMA is mostly found in normal and cancerous prostate cells. In addition, however, PSMA has also been found on the vasculature (blood vessels) that supply multiple types of cancer including colorectal, kidney, bladder, head and neck, breast, non-small cell lung, pancreas, ovary, esophagus and gliomas.
We hope that 177Lu-J591 will seek out blood vessels that supply these tumors and deliver a dose of radiation (from the 177Lu molecule) to the areas of cancer, without affecting target blood vessel that are not associated with the cancer.
Zirconium-89 (89Zr) is a radioactive tracer that allows special scans to be performed prior to administration of the study drug to determine where the antibody goes in the body and to screen the tumor's blood vessels to see if they attract J591. Again, DOTA is used to join the radioactive material to J591. 89Zr-J591 is not being given to treat cancer.
- Conditions
- Kidney Cancer, Head and Neck Cancer, Breast Cancer, Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Cancer
- Being tested
- 177Lu-J591
- Medical subject headings
- Kidney Neoplasms, Head and Neck Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Pancreatic Neoplasms, Ovarian Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-J591Drug
Also called monoclonal antibody J591
70 mCi/m2 of 177Lu-J591 will be administered on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| J591 | Experimental | Not described Receives: Drug: 177Lu-J591 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tumor perfusion as based on Dynamic Contrast Enhanced (DCE)-MRI study
Measured: Performed after administration of 177LuJ591 between Day 6-9 and on Day 29.
Change in tumor perfusion based on changes in cellularity as assessed using Diffusion-weighted imaging (DWI)
Measured: Performed after administration of 177LuJ591 between Day 6-9 and on Day 29.
Secondary outcomes (2)
Changes in response rate using Response evaluation criteria in solid tumors (RECIST) Criteria
Through RECIST criteria, objective response will be evaluated by taking into account the measurement of the longest diameter only for all target lesions on CT scans as well as normalization of serum tumor markers (if applicable).
Measured: Objective response will be evaluated from changes in baseline to Day 99 and repeated every 3 months until radiographic progression of disease.
Change in the number of subjects who achieve Progression Free Survival
Progression free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. This will be calculated from the time of treatment (day of 177Lu-J591 infusion) until radiographic progression or death.
Measured: Day 58 after administration with 177Lu-J591 and repeated every 3 months until radiographic progression of disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2018
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967577
- Sponsor's protocol ID
- 0902010212
- Status last verified
- Feb 2022
- First submitted
- 26 Aug 2009
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Nonprostate Metastatic Solid Tumors: A Pilot Study
- ClinicalTrials.gov ID
- NCT00967577
- Acronym / sponsor ID
- 0902010212
- Conditions
- Kidney Cancer, Head and Neck Cancer, Breast Cancer, Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jul 2009 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 28 Aug 2009 (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 evaluate changes in tumor blood flow and disease response to the investigation agent, 177Lu-J591.
Detailed description
177Lu-J591 is made up of two compounds called J591 and 177Lutetium (177Lu) that are joined together by a connecting molecule called "DOTA". J591 is a monoclonal antibody, or a type of protein. 177Lu is a radioactive molecule that is being tested for the possible treatment of cancer when joined to monoclonal antibodies. J591 attaches to a protein called prostate specific membrane antigen (PSMA) found in the body. PSMA is mostly found in normal and cancerous prostate cells. In addition, however, PSMA has also been found on the vasculature (blood vessels) that supply multiple types of cancer including colorectal, kidney, bladder, head and neck, breast, non-small cell lung, pancreas, ovary, esophagus and gliomas.
We hope that 177Lu-J591 will seek out blood vessels that supply these tumors and deliver a dose of radiation (from the 177Lu molecule) to the areas of cancer, without affecting target blood vessel that are not associated with the cancer.
Zirconium-89 (89Zr) is a radioactive tracer that allows special scans to be performed prior to administration of the study drug to determine where the antibody goes in the body and to screen the tumor's blood vessels to see if they attract J591. Again, DOTA is used to join the radioactive material to J591. 89Zr-J591 is not being given to treat cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| J591 | Experimental | Drug: 177Lu-J591 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically, or cytologically documented, advanced stage, malignant adult solid tumors (except prostate cancer) that are refractory to, or recurrent from, standard therapy or for which no curative standard therapy exists. This will include, but is not limited to patients with cancers of the kidney, urothelium, head and neck, breast, non-small cell lung, colorectal, pancreas, ovary, esophagus and gliomas.
- Metastatic or recurrent solid tumor malignancy defined by abnormal CT, MRI, PET scan, CXR and/or bone scan
- Progressive disease manifest by: Development of new lesions or an increase in size of preexisting lesions on imaging study or by physical examination.
- Subjects must have recovered from the acute toxicities of any prior therapy, and not received chemotherapy, radiation therapy or other investigational anticancer therapeutic drug for at least 4 weeks prior to J591 administration in this trial
- All subjects must have archived or current tissue (from a primary or metastatic focus) available for PSMA determination.
Key exclusion criteria (23 listed)
- Use of platelet transfusions within 4 weeks of treatment.
- Use of hematopoietic growth factors within 4 weeks of treatment.
- Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment.
- Prior radiation therapy encompassing >25% of skeleton.
- Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®)
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 |
|---|---|---|
| 177Lu-J591Also: monoclonal antibody J59170 mCi/m2 of 177Lu-J591 will be administered on Day 1. | Drug | J591 |
Primary outcome
Change in tumor perfusion as based on Dynamic Contrast Enhanced (DCE)-MRI study
Time frame: Performed after administration of 177LuJ591 between Day 6-9 and on Day 29.
Change in tumor perfusion based on changes in cellularity as assessed using Diffusion-weighted imaging (DWI)
Time frame: Performed after administration of 177LuJ591 between Day 6-9 and on Day 29.
2 secondary outcomes
Changes in response rate using Response evaluation criteria in solid tumors (RECIST) Criteria
Time frame: Objective response will be evaluated from changes in baseline to Day 99 and repeated every 3 months until radiographic progression of disease.
Change in the number of subjects who achieve Progression Free Survival
Time frame: Day 58 after administration with 177Lu-J591 and repeated every 3 months until radiographic progression of disease
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 2 Feb 2022.
- 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, MD 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 177Lu-J591 in people with Kidney Cancer and Head and Neck 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 7 inclusion and 23 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 2 Feb 2022. 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?
Change in tumor perfusion as based on Dynamic Contrast Enhanced (DCE)-MRI study (time frame: Performed after administration of 177LuJ591 between Day 6-9 and on Day 29.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2022.