NCT00441571

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2007

Completed
Last Updated

September 10, 2007

Status Verified

September 1, 2007

First QC Date

February 27, 2007

Last Update Submit

September 6, 2007

Conditions

Metastatic Prostate Cancer

Keywords

prostate cancerradiolabeled antibody

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • To determine the rate of HAMA induction as a result of treatment with 177Lu-CYT-500

Interventions

177Lu-CYT-500DRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Michael J Morris, M.D.

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Dwyer

CONTACT

609-750-8272kdwyer@cytogen.com

Colleen Gramkowski

CONTACT

609-750-8219cgramkowski@cytogen.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 27, 2007

First Posted

March 1, 2007

Study Start

February 1, 2007

Last Updated

September 10, 2007

Record last verified: 2007-09

Locations

US(1)