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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00081172
First received: April 7, 2004
Last updated: July 9, 2013
Last verified: April 2006
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Radiation: lutetium Lu 177 monoclonal antibody J591
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial Of Lu Radiolabeled Monoclonal Antibody HuJ591-GS (Lu-J591) In Patients With Metastatic Androgen-Independent Prostate Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Biochemical response as measured by prostate-specific antigen level at 8 weeks after treatment [ Designated as safety issue: No ]

Study Start Date: January 2004
Study Completion Date: May 2006
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081172

Locations
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Michael Morris, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00081172     History of Changes
Other Study ID Numbers: MSKCC-03144, CDR0000360629
Study First Received: April 7, 2004
Last Updated: July 9, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Androgens
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Immunologic Factors

ClinicalTrials.gov processed this record on August 20, 2014