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| Sponsor: | Cytogen Corporation |
|---|---|
| Information provided by: | Cytogen Corporation |
| ClinicalTrials.gov Identifier: | NCT00441571 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Prostate Cancer |
Drug: 177Lu-CYT-500 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate organ function:
Hematologic:
Exclusion Criteria:
Contacts and Locations| Contact: Karen Dwyer | 609-750-8272 | kdwyer@cytogen.com |
| Contact: Colleen Gramkowski | 609-750-8219 | cgramkowski@cytogen.com |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Michael J Morris 646-422-4469 morrism@mskcc.org | |
| Principal Investigator: | Michael J Morris, M.D. | Memorial Sloan-Kettering Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00441571 History of Changes |
| Other Study ID Numbers: | 500Lu01 |
| Study First Received: | February 27, 2007 |
| Last Updated: | September 6, 2007 |
| Health Authority: | United States: Food and Drug Administration |
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prostate cancer radiolabeled antibody |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male |
Prostatic Diseases Antibodies Immunoconjugates Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |