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Monoclonal Antibodies
Radiolabeled Antibody for Prostate Cancer (CYT-500 Trial)
Phase 1
Waitlist Available
Led By Michael J Morris, M.D.
Research Sponsored by Cytogen Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Adequate organ function: Hematologic: 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
CYT-500 Trial Summary
This trial will see if a new cancer treatment is safe and tolerable for patients. If it is, future trials will investigate the best dosage.
Who is the study for?
Men over 18 with advanced prostate cancer that's worsening despite low testosterone from treatment. They must have recovered from previous treatments, not be on other trials or therapies for the last 4 weeks, and have good organ function. No severe heart, lung diseases, active infections requiring IV antibiotics, or CNS tumors are allowed. Participants need to use effective contraception.Check my eligibility
What is being tested?
The trial is testing the safety of a new drug called 177Lu-CYT-500 in men with metastatic prostate cancer. It will determine the best dose and amount of this radiolabeled antibody for future studies.See study design
What are the potential side effects?
Possible side effects may include reactions related to radiation exposure such as fatigue, nausea, blood cell count changes leading to increased infection risk or bleeding problems, liver and kidney function alterations.
CYT-500 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is worsening after castration but doesn't need immediate palliative care.
Select...
My blood, liver, kidney, and clotting tests are within normal ranges.
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My cancer progressed after stopping hormone therapy that was combined with another treatment.
Select...
My liver function tests are within normal limits.
Select...
My kidney function is normal, with creatinine levels below 1.5 mg/dL or clearance above 60 mL/min.
Select...
I am 18 years old or older.
Select...
My testosterone levels are very low (<50 ng/ml).
Select...
I am able to care for myself but may not be able to do active work.
Select...
My testosterone levels are very low (<50 ng/ml).
Select...
I am 18 years old or older.
Select...
My prostate cancer progressed after stopping my initial hormone therapy.
Select...
I have recovered from previous cancer treatments and haven't had any in the last 4 weeks.
Select...
I am able to care for myself but may not be able to do active work.
CYT-500 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the biodistribution and pharmacokinetics of 177Lu-CYT-500
To determine the optimal antibody mass and dose of 177Lu-CYT-500 to be used for further study.
To investigate the safety and tolerability of treatment with 177Lu-CYT-500 in patients with progressive androgen-independent prostate cancer
Secondary outcome measures
To determine the rate of HAMA induction as a result of treatment with 177Lu-CYT-500
Find a Location
Who is running the clinical trial?
Cytogen CorporationLead Sponsor
5 Previous Clinical Trials
154 Total Patients Enrolled
2 Trials studying Prostate Cancer
45 Patients Enrolled for Prostate Cancer
Michael J Morris, M.D.Principal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
69 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer is worsening after castration but doesn't need immediate palliative care.I have recovered from previous cancer treatments and haven't had any in the last 4 weeks.My blood, liver, kidney, and clotting tests are within normal ranges.I do not have an active infection needing IV antibiotics.I've had radiation therapy that affected more than 25% of my bone marrow.I have previously received treatment with a radiolabeled monoclonal antibody.I have had specific diagnostic scans or treatments involving murine proteins.I am willing to use a condom during intercourse while on the drug and for 4 weeks after stopping.My cancer progressed after stopping hormone therapy that was combined with another treatment.My liver function tests are within normal limits.My kidney function is normal, with creatinine levels below 1.5 mg/dL or clearance above 60 mL/min.I am 18 years old or older.My prostate cancer is worsening after castration but doesn't need immediate palliative care.My testosterone levels are very low (<50 ng/ml).I have a tumor or cancer spread to my brain or spinal cord.I do not have severe heart or lung disease.My blood counts haven't recovered from my last cancer treatment.I am able to care for myself but may not be able to do active work.My testosterone levels are very low (<50 ng/ml).I am 18 years old or older.My prostate cancer progressed after stopping my initial hormone therapy.I have recovered from previous cancer treatments and haven't had any in the last 4 weeks.I am able to care for myself but may not be able to do active work.I have a history of autoimmune hepatitis or another autoimmune disease.My organs are working well.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this treatment suitable for individuals and can it be administered without risk?
"With limited clinical evidence of both efficacy and safety, our team at Power assigned this treatment a score of 1."
Answered by AI
Is this research experiment still recruiting participants?
"As per clinicaltrials.gov, this experiment is not currently recruiting patients. Although the initial posting was on February 1st 2007 and it has been altered most recently on September 6th 2007, there are 1258 alternative trials that are presently open to volunteers."
Answered by AI
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