Prostate CancerPhase 2NCT00081172
Radiolabeled Monoclonal Antibody in Treating Patients With Progressive Metastatic Androgen-Independent Adenocarcinoma (Cancer) of the Prostate
A Phase 2 study testing lutetium Lu 177 monoclonal antibody J591 in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- lutetium Lu 177 monoclonal antibody J591
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Jan 2004to May 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
New York Weill Cornell Cancer Center at Cornell University
New York, New York, 10021
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, 10032
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- lutetium Lu 177 monoclonal antibody J591
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lutetium Lu 177 monoclonal antibody J591Radiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical response as measured by prostate-specific antigen level at 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2004 (estimated)
- Study startJan 2004
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Michael Morris, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00081172
- Sponsor's protocol ID
- MSKCC-03144
- Other IDs
- CDR0000360629
- Status last verified
- Apr 2006
- First submitted
- 7 Apr 2004
- Last updated
- 10 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Of Lu Radiolabeled Monoclonal Antibody HuJ591-GS (Lu-J591) In Patients With Metastatic Androgen-Independent Prostate Cancer
- ClinicalTrials.gov ID
- NCT00081172
- Acronym / sponsor ID
- MSKCC-03144
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2004
- Study completion
- May 2006 (actual)
- First posted
- 8 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lutetium Lu 177 monoclonal antibody J591 | Radiation | – |
Primary outcome
Biochemical response as measured by prostate-specific antigen level at 8 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2013.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Morris, MD study chair
Memorial Sloan Kettering Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lutetium Lu 177 monoclonal antibody J591 in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical response as measured by prostate-specific antigen level at 8 weeks after treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2013.