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177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00859781
Recruitment Status : Recruiting
First Posted : March 11, 2009
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE March 10, 2009
First Posted Date  ICMJE March 11, 2009
Last Update Posted Date January 3, 2019
Actual Study Start Date  ICMJE June 2009
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2009)
Proportion free of radiographically evident metastases at 18 months by CT and/or MRI scan of the abdomen and pelvis, chest x-ray or CT scan of the chest and bone scan [ Time Frame: 18 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00859781 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2009)
PSA response rate [ Time Frame: every 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer
Official Title  ICMJE A Randomized Phase 2 Trial of 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With High-Risk Castrate Biochemically Relapsed Prostate Cancer After Local Therapy
Brief Summary The purpose of this study is to test the effectiveness of the experimental drug, 177Lu-J591 in combination with ketoconazole and hydrocortisone against prostate cancer.
Detailed Description

This research is being done because the standard treatments for prostate cancer that has returned (PSA is elevated) after surgery and/or radiation and progressed on initial hormonal therapy are not curative. Existing treatments, such as the ketoconazole used as part of this study may decrease PSA temporarily, but unfortunately the cancer continues to grow. This experimental drug is designed to seek out all of the prostate cancer cells and to deliver a lethal dose of radiation to the areas of cancer, but not to normal areas. Some of the normal organs (liver, kidney and bone marrow) do receive some radiation dose that is within the acceptable limits.

The experimental drug in this study includes an antibody (abbreviated: mAb) called "J591". It is a protein molecule which can bind to a specific site on a prostate cancer cell. A very energetic radioactive (an unstable atom) metal called 177Lutetium (abbreviated: 177Lu) is attached to the J591 antibody. The fully assembled drug is called "177Lu-J591". The study will assess the potential of the energy given off by the radioactive compound to kill cancer cell. This study may also involve the use of 111Indium (abbreviated 111In). This is also an energetic radioactive particle, but does not generally give off enough energy to kill cancer cells, but allows researchers to take pictures. This radioactive particle is also attached to the J591 antibody (called 111In-J591) and will serve as a placebo (treatment with no active medicine).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: 177Lu-J591
    177Lu-J591 70 mCi/m2 on day 29 (+/- 2 days) of treatment
    Other Name: J591
  • Drug: Ketoconazole
    Ketoconazole at a dose of 400 mg (two 200 mg tabs) to be taken orally (preferably on an empty stomach) three times per day (total daily dose of 1200 mg)
    Other Name: Nizoral
  • Drug: Hydrocortisone
    Hydrocortisone at a dose of 20 mg orally each morning, 10 mg orally each evening (total daily dose of 30 mg)
    Other Name: Cortef
  • Drug: 111In-J591
    111In-J591 at a dose of 5 mCi on day 29 (+/- 2 days) of treatment
    Other Name: J591
Study Arms  ICMJE
  • Experimental: 1. 177Lu-J591+Ketoconzole
    Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 177Lu-J591 Infusion, continue ketoconazole and hydrocortisone
    Interventions:
    • Drug: 177Lu-J591
    • Drug: Ketoconazole
    • Drug: Hydrocortisone
  • Placebo Comparator: 2. 111In-J591 + ketoconazole
    Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 111In-J591 (placebo) Infusion, continue ketoconazole and hydrocortisone
    Interventions:
    • Drug: Ketoconazole
    • Drug: Hydrocortisone
    • Drug: 111In-J591
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 10, 2009)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate previously treated with surgery and/or radiotherapy.
  • Biochemical progression (rising PSA) after medical or surgical castration
  • High risk of systemic progression defined as:

    1. Rising PSA as defined above and either:
    2. Absolute PSA > 20 ng/mL AND/OR
    3. PSA doubling time < 8 months
  • No evidence of local recurrence or distant metastases
  • Age >18 years.
  • Serum testosterone < 50 ng/ml
  • Patients capable of fathering children must agree to use an effective method of contraception for the duration of the trial.
  • Subjects on bisphosphonate therapy must be on a stable dose and must have started therapy > 4 weeks prior to protocol therapy.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Use of red blood cell or platelet transfusions within 4 weeks of treatment
  • Use of hematopoietic growth factors within 4 weeks of treatment
  • Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment
  • Prior radiation therapy encompassing >25% of skeleton
  • Prior treatment with 89-Strontium or 153-Samarium containing compounds (e.g. Metastron®, Quadramet®)
  • Platelet count <150,000/mm3
  • Absolute neutrophil count (ANC) <2,000/mm3
  • Hematocrit <30 percent or Hemoglobin < 10 g/dL
  • Abnormal coagulation profile (PT or INR, PTT) > 1.3x ULN
  • Serum creatinine >2.5 mg/dL
  • AST (SGOT) >2x ULN
  • Bilirubin (total) >1.5x ULN
  • Serum calcium >11 mg/dL
  • Active serious infection
  • Active angina pectoris or NY Heart Association Class III-IV
  • Karnofsky Performance Status <70
  • Life expectancy <12 months
  • History of deep vein thrombosis and/or pulmonary embolus within 3 months of study entry
  • Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
  • Prior investigational therapy (medications or devices) within 6 weeks of treatment.
  • Prior use of ketoconazole for the purposes of prostate cancer therapy
  • Known history of HIV.
  • Currently active other malignancy other than non-melanoma skin cancer.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: GUONC Research Team guonc@med.cornell.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00859781
Other Study ID Numbers  ICMJE 0810010067
J591+Ketoconazole ( Other Identifier: Weill Cornell Medical College )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Scott T Tagawa, M.D. Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date January 2019

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