Recruiting
Phase 1

177Lu-CYT-500

Sponsor:

Cytogen Corporation

Code:

NCT00441571

Conditions

Metastatic Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

177Lu-CYT-500

Study Details

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.

Conditions

Metastatic Prostate Cancer

Study ID

NCT00441571

Start date

Feb, 2007

Status verified date

Sep, 2007

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

177Lu-CYT-500

Primary outcome measure

  • To investigate the safety and tolerability of treatment with 177Lu-CYT-500 in patients with progressive androgen-independent prostate cancer [ Time Frame: undefined ]
  • To determine the optimal antibody mass and dose of 177Lu-CYT-500 to be used for further study. [ Time Frame: undefined ]
  • To determine the biodistribution and pharmacokinetics of 177Lu-CYT-500 [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Karen Dwyer

609-750-8272kdwyer@cytogen.com

Colleen Gramkowski

609-750-8219cgramkowski@cytogen.com

Locations

Memorial Sloan-Kettering Cancer Center

Recruiting

New York, New York, United States, 10021

Contacts

Michael J Morris

646-422-4469morrism@mskcc.org

More Information

Sponsor

Cytogen Corporation

Last update posted

Sep 10, 2007

Last verified

Sep, 2007

Keywords

  • prostate cancer
  • radiolabeled antibody

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cytogen Corporation on 2007-09-10.