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Prostate CancerPhase 2NCT00024232

Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer

A Phase 2 study testing monoclonal antibody huJ591 in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site 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: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have prostate cancer that has not responded to hormone… 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?
monoclonal antibody huJ591
How many people
Not given
Where
1 siteUnited States
Study dates
Jun 2001to Feb 2004
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 prostate cancer
  • Disease progression after prior castration
  • At least 3 rising PSA levels at least 1 week apart OR 2 rising levels at least 4 weeks apart
  • New osseous lesions on bone scan and/or more than 25% increase in bidimensionally measurable soft tissue disease or appearance of new sites of disease by CT scan or MRI
  • Testosterone no greater than 50 ng/mL
  • Medical therapy (e.g., gonadotropin-releasing hormone analogues) to maintain castrate level of testosterone should continue in the absence of surgical orchiectomy
  • Progression of disease after discontinuation of prior anti-androgen therapy
  • No requirement for palliative therapy within the past 12 weeks
  • No active CNS or epidural primary tumor OR active CNS or epidural metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC greater than 3,500/mm3
  • Platelet count greater than 100,000/mm3

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • Gamma-glutamyl-transferase less than upper limit of normal (ULN)
  • AST less than ULN
  • PT less than 14 seconds
  • No prior autoimmune hepatitis

Renal:

  • Creatinine less than 1.5 mg/dL OR
  • Creatinine clearance greater than 60 mL/min

Cardiovascular:

  • No clinically significant cardiac disease (New York Heart Association class III or IV)

Pulmonary:

  • No severe debilitating pulmonary disease

Other:

  • Fertile patients must use effective contraception
  • No active uncontrolled infection or infection requiring IV antibiotics
  • No prior autoimmune disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior murine protein for diagnostic or therapeutic purposes
  • No other concurrent anticancer immunotherapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy and recovered
  • No concurrent anticancer chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent anticancer hormonal therapy

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered
  • Concurrent radiotherapy to localized sites of disease (e.g., bone) allowed if the site does not contain sole measurable lesion

Surgery:

  • See Disease Characteristics
  • No concurrent surgery

Other:

  • Recovered from all prior therapy
  • At least 4 weeks since prior therapeutic investigational anticancer drugs
  • At least 4 weeks since prior participation in therapeutic clinical trial with an experimental drug
  • No prior diagnostic ProstaScint, Myoscint, or Oncoscint scans
  • No other concurrent therapeutic investigational anticancer agents
  • No concurrent participation in other therapeutic clinical trial with an experimental drug

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

Other trials in United States

About this study

Official title: Pilot Trial of Humanized Monoclonal Antibody J591 in Patients With Progressive Androgen-Independent Prostate Cancer

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have prostate cancer that has not responded to hormone therapy.

Read the detailed description

OBJECTIVES:

  • Determine the antitumor effects of monoclonal antibody huJ591 in patients with progressive androgen-independent prostate cancer.
  • Determine the biodistribution and dosimetry of this antibody in these patients.
  • Determine the effect on biodistribution of the delivery sequence of unlabeled vs indium In 111-labeled antibody in these patients.
  • Determine the HAHA response in patients treated with this regimen.
  • Correlate the dose of monoclonal antibody huJ591 with antibody-dependent cellular cytotoxicity in these patients.

OUTLINE: Patients are assigned to one of two treatment groups.

  • Group I: Patients receive monoclonal antibody huJ591 IV followed by indium In 111 monoclonal antibody huJ591 on day 1.
  • Group II: Patients receive monoclonal antibody huJ591 concurrently with indium In 111 monoclonal antibody huJ591 as in group I.

Treatment in both groups repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for 4 weeks and then monthly for 3 months.

PROJECTED ACCRUAL: A total of 14 patients (7 per treatment group) will be accrued for this study.

Conditions
Prostate Cancer
Being tested
monoclonal antibody huJ591
Keywords
stage IV prostate cancer, recurrent 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.

  • monoclonal antibody huJ591Biological

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJun 2001
  3. Primary completionFeb 2004
  4. Study completionFeb 2004

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00024232
Sponsor's protocol ID
MSKCC-01030
Other IDs
CDR0000068903, NCI-G01-2013
Status last verified
Jun 2013
First submitted
13 Sep 2001
Last updated
18 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing monoclonal antibody huJ591 in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center 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?

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 18 Jun 2013. 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 18 Jun 2013.

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