Clinical Trials /

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

NCT00859781

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: 0810010067
  • SECONDARY ID: J591+Ketoconazole
  • NCT ID: NCT00859781

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
177Lu-J591J5911. 177Lu-J591+Ketoconzole
KetoconazoleNizoral1. 177Lu-J591+Ketoconzole
HydrocortisoneCortef1. 177Lu-J591+Ketoconzole
111In-J591J5912. 111In-J591 + ketoconazole

Purpose

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).
    

Trial Arms

NameTypeDescriptionInterventions
1. 177Lu-J591+KetoconzoleExperimentalKetoconazole 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
  • 177Lu-J591
  • Ketoconazole
  • Hydrocortisone
2. 111In-J591 + ketoconazolePlacebo ComparatorKetoconazole 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
  • Ketoconazole
  • Hydrocortisone
  • 111In-J591

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Secondary Outcome Measures

Measure:PSA response rate
Time Frame:every 4 weeks
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Weill Medical College of Cornell University

Trial Keywords

  • Prostate

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