- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00441571
Safety Study of a Radiolabeled Antibody (7E11) in Patients With Progressive Hormone Refractory Prostate Cancer (CYT-500)
September 6, 2007 updated by: Cytogen Corporation
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Karen Dwyer
- Phone Number: 609-750-8272
- Email: kdwyer@cytogen.com
Study Contact Backup
- Name: Colleen Gramkowski
- Phone Number: 609-750-8219
- Email: cgramkowski@cytogen.com
Study Locations
-
-
New York
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New York, New York, United States, 10021
- Recruiting
- Memorial Sloan-Kettering Cancer Center
-
Contact:
- Michael J Morris
- Phone Number: 646-422-4469
- Email: morrism@mskcc.org
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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 Outcome Measures
Outcome Measure |
---|
To determine the rate of HAMA induction as a result of treatment with 177Lu-CYT-500
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael J Morris, M.D., Memorial Sloan Kettering Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion
December 7, 2022
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
February 27, 2007
First Submitted That Met QC Criteria
February 28, 2007
First Posted (Estimate)
March 1, 2007
Study Record Updates
Last Update Posted (Estimate)
September 10, 2007
Last Update Submitted That Met QC Criteria
September 6, 2007
Last Verified
September 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 500Lu01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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