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

Metastatic Prostate Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00441571
• Other study ID #: 500Lu01
• Status: Recruiting
• Phase: Phase 1
• First received: February 27, 2007
• Last updated: September 6, 2007
• Start date: February 2007

Study information

• Verified date: September 2007
• Source: Cytogen Corporation
• Contact: Karen Dwyer
• Phone: 609-750-8272
• Email: kdwyer[@]cytogen.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 177Lu-CYT-500

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Cytogen Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the safety and tolerability of treatment with 177Lu-CYT-500 in patients with progressive androgen-independent prostate cancer
Primary	To determine the optimal antibody mass and dose of 177Lu-CYT-500 to be used for further study.
Primary	To determine the biodistribution and pharmacokinetics of 177Lu-CYT-500
Secondary	To determine the rate of HAMA induction as a result of treatment with 177Lu-CYT-500