Metastatic Prostate CancerPhase 1CYT-500NCT00441571
Safety Study of a Radiolabeled Antibody (7E11) in Patients With Progressive Hormone Refractory Prostate Cancer
A Phase 1 study testing 177Lu-CYT-500 in people with Metastatic Prostate Cancer, run by Cytogen Corporation at 1 site in United States.
Trial summary
The proposed phase 1 clinical trial will investigate the safety and tolerability of 177Lu-CYT-500 in patients with metastatic prostate cancer and determine the optimal antibody mass and dose of 177Lu to be used for further study. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- 177Lu-CYT-500
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to not given
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically documented prostate cancer that is progressing following castration. The disease should not be progressing so as to require palliative treatment within 12 weeks of enrollment based on clinical assessment by the investigator. All patients must have assessable disease by radionuclide and/or radiographic studies.
- Castrate levels of testosterone (<50 ng/ml).
- Karnofsky performance status >60%.
- Patients whose initial hormone treatment (exclusive of neoadjuvant hormone therapy) was a combined androgen blockade approach, e.g. an orchiectomy plus an anti-androgen, or gonadotropin releasing hormone analog and an anti-androgen, must show progression of disease following withdrawal of the anti-androgen prior to enrollment.
- Adequate organ function:
- Hematologic:
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- ANC >1,500/mm3
- Platelet count >100,000/mm3
- Hepatic: Bilirubin <1.5 mg/dL and AST<1.5X's the ULN
- Renal: Creatinine <1.5 mg/dL or creatinine clearance > 60 mL/min.
- Coagulation: Prothrombin time < institutional UNL.
- Patients must have recovered from the acute toxicities of any prior therapy, and not received chemotherapy, radiation therapy or other investigational anticancer therapeutic drugs for at least 4 weeks prior to entry into the trial.
- Patients must be at least 18 years of age.
- Subjects will be informed as to the potential risk of procreation while participating in this trial and will be advised to use effective contraception during the entire study period.
- Patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the institution.
Who cannot join
- Clinically significant cardiac disease (New York Heart Association Class III or IV), or severe debilitating pulmonary disease.
- Active CNS or epidural primary tumor or active CNS or epidural metastases.
- An active uncontrolled infection or an infection requiring intravenous antibiotic treatment.
- Participation in another therapeutic clinical trial with an experimental drug, concurrently or within the 4 weeks prior to dosing in this study.
- Lack of recovery from the myelosuppressive effects of prior radiation therapy or chemotherapy.
- Patients who have undergone diagnostic ProstaScint, Myoscint, or Oncoscint scans, or have undergone any other prior administration of a murine protein for diagnostic or therapeutic purposes, without regard to HAMA test results.
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- Patients with a history of autoimmune hepatitis or history of autoimmune disease.
- Prior radiation therapy encompassing >25% of the bone marrow
- Prior systemic administration of a therapeutic radiolabeled monoclonal antibody.
- Patients who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse, while taking the drug and for 4 weeks after stopping treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Michael J Morris, 646-422-4469, morrism@mskcc.org
About this study
Official title: A Phase 1 Study of Radiolabeled Monoclonal Antibody 7E11-C5.3(177Lu-meO-DOTA-7E11;CYT-500) in Patients With Progressive Androgen-Independent Prostate Cancer
The proposed phase 1 clinical trial will investigate the safety and tolerability of 177Lu-CYT-500 in patients with metastatic prostate cancer and determine the optimal antibody mass and dose of 177Lu to be used for further study.
Read the detailed description
The proposed phase I clinical trial will investigate the safety and tolerability of 177Lu-CYT-500 and determine the optimal antibody mass and dose of 177Lu to be used for further study. The biodistribution and pharmacokinetics will also be assessed. Patients with histologically documented prostate cancer that is progressing following castration will be eligible. Two antibody masses will be explored in cohort 1 before dose escalation of the 177Lu begins. If the two antibody masses show no difference in pharmacokinetics or biodistribution, then the lower of the doses will be used. The radiation dose will be escalated in subsequent cohorts. Dose escalation will be permitted when the last patient accrued to the previous cohort has demonstrated count recovery in cycle 1 such that DLT has not been defined.
- Conditions
- Metastatic Prostate Cancer
- Being tested
- 177Lu-CYT-500
- Keywords
- prostate cancer, radiolabeled antibody
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-CYT-500Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the safety and tolerability of treatment with 177Lu-CYT-500 in patients with progressive androgen-independent prostate cancer
To determine the optimal antibody mass and dose of 177Lu-CYT-500 to be used for further study.
To determine the biodistribution and pharmacokinetics of 177Lu-CYT-500
Secondary outcomes (1)
To determine the rate of HAMA induction as a result of treatment with 177Lu-CYT-500
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cytogen Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael J Morris, M.D., Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441571
- Sponsor's protocol ID
- 500Lu01
- Acronym
- CYT-500
- Status last verified
- Sep 2007
- First submitted
- 27 Feb 2007
- Last updated
- 10 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Radiolabeled Monoclonal Antibody 7E11-C5.3(177Lu-meO-DOTA-7E11;CYT-500) in Patients With Progressive Androgen-Independent Prostate Cancer
- ClinicalTrials.gov ID
- NCT00441571
- Acronym / sponsor ID
- CYT-500 / 500Lu01
- Conditions
- Metastatic Prostate Cancer
- Keywords
- prostate cancer, radiolabeled antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cytogen CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- First posted
- 1 Mar 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 proposed phase 1 clinical trial will investigate the safety and tolerability of 177Lu-CYT-500 in patients with metastatic prostate cancer and determine the optimal antibody mass and dose of 177Lu to be used for further study.
Detailed description
The proposed phase I clinical trial will investigate the safety and tolerability of 177Lu-CYT-500 and determine the optimal antibody mass and dose of 177Lu to be used for further study. The biodistribution and pharmacokinetics will also be assessed. Patients with histologically documented prostate cancer that is progressing following castration will be eligible. Two antibody masses will be explored in cohort 1 before dose escalation of the 177Lu begins. If the two antibody masses show no difference in pharmacokinetics or biodistribution, then the lower of the doses will be used. The radiation dose will be escalated in subsequent cohorts. Dose escalation will be permitted when the last patient accrued to the previous cohort has demonstrated count recovery in cycle 1 such that DLT has not been defined.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically documented prostate cancer that is progressing following castration. The disease should not be progressing so as to require palliative treatment within 12 weeks of enrollment based on clinical assessment by the investigator. All patients must have assessable disease by radionuclide and/or radiographic studies.
- Castrate levels of testosterone (<50 ng/ml).
- Karnofsky performance status >60%.
- Patients whose initial hormone treatment (exclusive of neoadjuvant hormone therapy) was a combined androgen blockade approach, e.g. an orchiectomy plus an anti-androgen, or gonadotropin releasing hormone analog and an anti-androgen, must show progression of disease following withdrawal of the anti-androgen prior to enrollment.
- Adequate organ function:
Key exclusion criteria (10 listed)
- Clinically significant cardiac disease (New York Heart Association Class III or IV), or severe debilitating pulmonary disease.
- Active CNS or epidural primary tumor or active CNS or epidural metastases.
- An active uncontrolled infection or an infection requiring intravenous antibiotic treatment.
- Participation in another therapeutic clinical trial with an experimental drug, concurrently or within the 4 weeks prior to dosing in this study.
- Lack of recovery from the myelosuppressive effects of prior radiation therapy or chemotherapy.
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-CYT-500 | Drug | – |
Primary outcome
To investigate the safety and tolerability of treatment with 177Lu-CYT-500 in patients with progressive androgen-independent prostate cancer
To determine the optimal antibody mass and dose of 177Lu-CYT-500 to be used for further study.
To determine the biodistribution and pharmacokinetics of 177Lu-CYT-500
1 secondary outcome
To determine the rate of HAMA induction as a result of treatment with 177Lu-CYT-500
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2007.
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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.
Michael J Morris, M.D. principal investigator
Memorial Sloan Kettering Cancer Center
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-CYT-500 in people with Metastatic Prostate Cancer, run by Cytogen Corporation 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 15 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 10 Sep 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen Dwyer (609-750-8272, kdwyer@cytogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the safety and tolerability of treatment with 177Lu-CYT-500 in patients with progressive androgen-independent prostate cancer. The study lists 3 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 10 Sep 2007; AzTrials last refreshed its copy on 8 Nov 2026.