Radiolabeled Monoclonal Antibody in Treating Patients With Progressive Metastatic Androgen-Independent Adenocarcinoma (Cancer) of the Prostate

Prostate Cancer Clinical Trial

Official title:

A Phase II Trial Of Lu Radiolabeled Monoclonal Antibody HuJ591-GS (Lu-J591) In Patients With Metastatic Androgen-Independent Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00081172
• Other study ID #: MSKCC-03144
• Secondary ID: CDR0000360629
• Status: Completed
• Phase: Phase 2
• First received: April 7, 2004
• Last updated: July 9, 2013
• Start date: January 2004
• Est. completion date: May 2006

Study information

• Verified date: April 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells.

PURPOSE: This phase II trial is studying how well radiolabeled monoclonal antibody works in treating patients with progressive metastatic androgen-independent adenocarcinoma (cancer) of the prostate.

Description:

OBJECTIVES:

Primary

• Determine the prostate-specific antigen (PSA) response rate in patients with progressive metastatic androgen-independent adenocarcinoma of the prostate treated with lutetium Lu 177 monoclonal antibody J591.

• Determine the measurable disease response rate in patients treated with this drug.

Secondary

• Determine the toxicity of this drug in these patients.

• Determine the duration of biochemical PSA and/or measurable disease response in patients treated with this drug.

• Determine the incidence of human anti-J591 antibody (HAHA) response in patients treated with this drug.

• Correlate hematological toxicity of this drug with bone marrow involvement (bone scan index) in these patients.

• Determine the survival rate in patients treated with this drug.

• Determine the targeting of this drug to known tumor sites in these patients.

• Determine the tumor-absorbed radiation dose in patients treated with this drug.

OUTLINE: This is a multicenter, open-label study.

Patients receive a single dose of lutetium Lu 177 monoclonal antibody J591 IV on day 1. Patients then undergo radionuclide scanning between days 6-8 to confirm tumor targeting by the study drug.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 17-32 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• Metastatic disease

• Progressive disease after prior antiandrogen therapy, as evidenced by at least 1 of the following parameters:

• New osseous lesions on bone scan

• Greater than 25% increase in the sum of the products of the longest perpendicular diameters of the lesions OR the appearance of new lesions on MRI or CT scan

• Rising prostate-specific antigen (PSA) despite adequate medical or surgical castration therapy

• Consecutive increase in PSA, determined by two separate measurements taken at least 1 week apart and confirmed by a third, and if necessary, a fourth measurement

• PSA must be = 5 ng/mL and = 25% above the previous nadir

• Measurable or evaluable disease

• Serum testosterone = 50 ng/dL

• No confluent lesions involving axial and appendicular skeleton on bone scan ("superscan")

PATIENT CHARACTERISTICS:

Age

• Over 18

Performance status

• Karnofsky 70-100%

Life expectancy

• At least 6 months

Hematopoietic

• Absolute neutrophil count = 2,000/mm^3

• Hematocrit = 30%

• Hemoglobin = 10 g/dL

• Platelet count = 150,000/mm^3

• No serious hematologic illness that would preclude study participation

Hepatic

• AST = 2 times upper limit of normal (ULN)

• Bilirubin = 1.5 times ULN

• PTT normal

• PT normal OR

• INR normal

• No serious hepatic illness that would preclude study participation

Renal

• Creatinine = 2.5 mg/dL

• Calcium = 11 mg/dL

• No serious renal illness that would preclude study participation

Cardiovascular

• No New York Heart Association class III or IV heart disease

• No active angina pectoris

• No prior deep vein thrombophlebitis within the past 3 months

• No other serious cardiac illness that would preclude study participation

Pulmonary

• No pulmonary embolus within the past 3 months

• No other serious respiratory illness that would preclude study participation

Other

• Fertile patients must use effective contraception

• HIV negative

• No serious CNS illness that would preclude study participation

• No active serious infection not controlled by antibiotics

• No other serious illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 2 weeks since prior red blood cell or platelet transfusions

• More than 2 weeks since prior hematopoietic growth factors

• No prior monoclonal antibody therapy except ProstaScint®

• No other concurrent monoclonal antibody-based therapy

• No concurrent medication to support platelet count (e.g., oprelvekin)

Chemotherapy

• More than 4 weeks since prior cytotoxic chemotherapy

Endocrine therapy

• See Disease Characteristics

• Concurrent luteinizing hormone-releasing hormone (LHRH) analog allowed provided 1 of the following is true:

• Treatment is maintained during study participation

• Treatment is terminated at least 10 weeks (for 1-month depot preparations), 24 weeks (for 3-month depot preparations), or 32 weeks (for 4-month depot preparations) prior to study entry

• More than 4 weeks since prior corticosteroids

• More than 4 weeks since prior adrenal hormone inhibitors

• Concurrent low-dose prednisone (= 5mg/day) for adrenal insufficiency allowed

• No concurrent finasteride

Radiotherapy

• More than 4 weeks since prior radiotherapy

• No prior radiotherapy to > 25% of skeleton

• No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium-containing compounds (e.g., Metastron® or Quadramet®)

Surgery

• Not specified

Other

• More than 4 weeks since prior PC-SPES

• More than 4 weeks since prior investigational therapy (medications or devices)

• At least 1 week since prior aspirin and/or nonsteroidal anti-inflammatory agents possessing antiplatelet activity

• At least 1 week since prior antiplatelet medication, including the following:

• Abciximab

• Cilostazol

• Clopidogrel

• Dipyridamole

• Ticlopidine

• No concurrent anticoagulant medications (for platelet count < 50,000/mm^3), including the following:

• Dalteparin

• Danaparoid

• Enoxaparin

• Heparin

• Warfarin

• No other concurrent investigational therapy

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• lutetium Lu 177 monoclonal antibody J591

Locations

Country	Name	City	State
United States	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	New York Weill Cornell Cancer Center at Cornell University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical response as measured by prostate-specific antigen level at 8 weeks after treatment			No