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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

  1. 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.

  1. First posted8 Apr 2004 (estimated)
  2. Study startJan 2004
  3. Study completionMay 2006

Resources

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)
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

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.

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