Prostatic NeoplasmsPhase 2NCT00040586
Phase II Trial of Monoclonal Antibody (J591) in Combination With Low-Dose Subcutaneous Interleukin-2
A Phase 2 study testing Monoclonal Antibody J591 and Recombinant Interleukin-2 in people with Prostatic Neoplasms, run by BZL Biologics at 1 site in United States.
Trial summary
The monoclonal antibody J591 is being investigated as therapy for patients with prostate cancer, in combination with recombinant interleukin-2 (Proleukin, Aldesleukin). The study is an open-label, non-randomized phase II study for patients with documented hormone refractory prostate cancer. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Monoclonal Antibody J591 and Recombinant Interleukin-2
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of entry.
- History of CNS metastasis, and/or history of seizure and/or stroke.
- Lab values: ANC<1500/mm3; platelet count<100,000/mm3; serum creatinine>2.0; SGOT>2 x normal; bilirubin (total)>1.5; serum calcium> or equal to 11.5.
- Active serious infection not controlled by antibiotics.
- Active angina pectoris or NYHA Class III-IV.
- Karnofsky Performance Status <60.
Show all 10Show fewer
- Life Expectancy < 3 months.
- Age< 21y.
- 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.
- Untreated thyroid disease, with the exception of treated and stable hyperthyroidism or hypothyroidism for at least 4 weeks prior to entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital Medical Oncology/Urology Clinics
New York, New York, 10021
About this study
Official title: Phase II Trial of Monoclonal Antibody J591 in Combination With Low-Dose Interleukin-2 in Patients With Recurrent Prostate Cancer
The monoclonal antibody J591 is being investigated as therapy for patients with prostate cancer, in combination with recombinant interleukin-2 (Proleukin, Aldesleukin). The study is an open-label, non-randomized phase II study for patients with documented hormone refractory prostate cancer.
Read the detailed description
In this Phase II, open label study, patients will receive daily low-dose subcutaneous rIL-2 (1.2 x 10^6 IU/m^2/day) continuously beginning on day 1. Patients will receive 3 weeks of IL-2, and on day 22 will receive the monoclonal antibody huJ591 via I.V. (25mg/m^2) for 3 consecutive weeks. Il-2 will be continued for 2 additional weeks for a total of 8 weeks. The 8 week regimen will constitute 1 cycle of therapy. Patients who have responded to therapy or have stable disease will be eligible for additional cycles of therapy.
- Conditions
- Prostatic Neoplasms
- Being tested
- Monoclonal Antibody J591, Recombinant Interleukin-2
- Keywords
- hormone-refractory
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monoclonal Antibody J591Drug
Recombinant Interleukin-2Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2002 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- BZL Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00040586
- Sponsor's protocol ID
- 1100-471
- Status last verified
- Jul 2002
- First submitted
- 1 Jul 2002
- Last updated
- 22 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Monoclonal Antibody J591 in Combination With Low-Dose Interleukin-2 in Patients With Recurrent Prostate Cancer
- ClinicalTrials.gov ID
- NCT00040586
- Acronym / sponsor ID
- 1100-471
- Conditions
- Prostatic Neoplasms
- Keywords
- hormone-refractory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- BZL BiologicsIndustry (pharma, biotech, devices)
- First posted
- 2 Jul 2002 (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.
The monoclonal antibody J591 is being investigated as therapy for patients with prostate cancer, in combination with recombinant interleukin-2 (Proleukin, Aldesleukin). The study is an open-label, non-randomized phase II study for patients with documented hormone refractory prostate cancer.
Detailed description
In this Phase II, open label study, patients will receive daily low-dose subcutaneous rIL-2 (1.2 x 10^6 IU/m^2/day) continuously beginning on day 1. Patients will receive 3 weeks of IL-2, and on day 22 will receive the monoclonal antibody huJ591 via I.V. (25mg/m^2) for 3 consecutive weeks. Il-2 will be continued for 2 additional weeks for a total of 8 weeks. The 8 week regimen will constitute 1 cycle of therapy. Patients who have responded to therapy or have stable disease will be eligible for additional cycles of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of entry.
- History of CNS metastasis, and/or history of seizure and/or stroke.
- Lab values: ANC<1500/mm3; platelet count<100,000/mm3; serum creatinine>2.0; SGOT>2 x normal; bilirubin (total)>1.5; serum calcium> or equal to 11.5.
- Active serious infection not controlled by antibiotics.
- Active angina pectoris or NYHA Class III-IV.
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 |
|---|---|---|
| Monoclonal Antibody J591 | Drug | – |
| Recombinant Interleukin-2 | Drug | – |
Primary outcome
Not reported in the source record.
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 22 Jan 2007.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Monoclonal Antibody J591 and Recombinant Interleukin-2 in people with Prostatic Neoplasms, run by BZL Biologics at 1 site 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?
The sponsor lists 0 inclusion and 10 exclusion criteria. 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 22 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 22 Jan 2007.