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

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ClinicalTrials.gov Identifier: NCT00081172
Recruitment Status : Completed
First Posted : April 8, 2004
Last Update Posted : July 10, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

April 7, 2004
April 8, 2004
July 10, 2013
January 2004
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Biochemical response as measured by prostate-specific antigen level at 8 weeks after treatment
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Complete list of historical versions of study NCT00081172 on ClinicalTrials.gov Archive Site
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Radiolabeled Monoclonal Antibody in Treating Patients With Progressive Metastatic Androgen-Independent Adenocarcinoma (Cancer) of the Prostate
A Phase II Trial Of Lu Radiolabeled Monoclonal Antibody HuJ591-GS (Lu-J591) In Patients With Metastatic Androgen-Independent Prostate Cancer

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.

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.

Interventional
Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
Radiation: lutetium Lu 177 monoclonal antibody J591
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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May 2006
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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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00081172
MSKCC-03144
CDR0000360629 ( Registry Identifier: PDQ (Physician Data Query) )
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Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Michael Morris, MD Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP