Safety Study of a Radiolabeled Antibody (7E11) in Patients With Progressive Hormone Refractory Prostate Cancer (CYT-500)
Primary Purpose
Metastatic Prostate Cancer
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
177Lu-CYT-500
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Prostate Cancer focused on measuring prostate cancer, radiolabeled antibody
Eligibility Criteria
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.
Sites / Locations
- Memorial Sloan-Kettering Cancer CenterRecruiting
Outcomes
Primary Outcome Measures
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
To determine the rate of HAMA induction as a result of treatment with 177Lu-CYT-500
Full Information
NCT ID
NCT00441571
First Posted
February 27, 2007
Last Updated
September 6, 2007
Sponsor
Cytogen Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00441571
Brief Title
Safety Study of a Radiolabeled Antibody (7E11) in Patients With Progressive Hormone Refractory Prostate Cancer
Acronym
CYT-500
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Cytogen Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Prostate Cancer
Keywords
prostate cancer, radiolabeled antibody
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
177Lu-CYT-500
Primary Outcome Measure Information:
Title
To investigate the safety and tolerability of treatment with 177Lu-CYT-500 in patients with progressive androgen-independent prostate cancer
Title
To determine the optimal antibody mass and dose of 177Lu-CYT-500 to be used for further study.
Title
To determine the biodistribution and pharmacokinetics of 177Lu-CYT-500
Secondary Outcome Measure Information:
Title
To determine the rate of HAMA induction as a result of treatment with 177Lu-CYT-500
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Dwyer
Phone
609-750-8272
Email
kdwyer@cytogen.com
First Name & Middle Initial & Last Name or Official Title & Degree
Colleen Gramkowski
Phone
609-750-8219
Email
cgramkowski@cytogen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Morris, M.D.
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael J Morris
Phone
646-422-4469
Email
morrism@mskcc.org
12. IPD Sharing Statement
Learn more about this trial
Safety Study of a Radiolabeled Antibody (7E11) in Patients With Progressive Hormone Refractory Prostate Cancer
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