Safety Study of a Radiolabeled Antibody (7E11) in Patients With Progressive Hormone Refractory Prostate Cancer (CYT-500)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Cytogen Corporation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cytogen Corporation
ClinicalTrials.gov Identifier:
NCT00441571
First received: February 27, 2007
Last updated: September 6, 2007
Last verified: September 2007
  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 1

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

Resource links provided by NLM:


Further study details as provided by Cytogen Corporation:

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

Estimated Enrollment: 30
Study Start Date: February 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00441571

Contacts
Contact: Karen Dwyer 609-750-8272 kdwyer@cytogen.com
Contact: Colleen Gramkowski 609-750-8219 cgramkowski@cytogen.com

Locations
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   
Sponsors and Collaborators
Cytogen Corporation
Investigators
Principal Investigator: Michael J Morris, M.D. Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

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

Keywords provided by Cytogen Corporation:
prostate cancer
radiolabeled antibody

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on April 17, 2014