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Pancreatic NeoplasmsPhase 1/2NCT00041639

Safety Study of 90Y-hMN14 to Treat Pancreatic Cancer

A Phase 1/2 study testing hMN14 (labetuzumab) in people with Pancreatic Neoplasms, run by Gilead Sciences at 10 sites in 4 countries.

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

The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in the treatment of pancreatic cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Neoplasms
What is being tested?
hMN14 (labetuzumab)
How many people
75 participants
Where
10 sitesin 4 countries
Study dates
Jan 2000to Dec 2003
Phase
Phase 1/2
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Disease Characteristics:

  • Patients with a documented histologic or cytologic diagnosis of a pancreatic malignancy
  • Patients with recurrent, advanced and/or metastatic disease, who have either failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority.
  • Patients with at least one identified (confirmed) and measureable tumor site.

Prior/Concurrent Therapy:

  • Surgery: Patients are excluded if they have had major surgery either during or within four weeks prior to study entry.
  • Chemotherapy: Patients must have failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority.
  • Biologic Therapy: Patients who have received a chimeric, CDR-grafted (humanized), or human IgG will be eligible provided pre-study evaluations demonstrate no significant reactivity with hMN14 IgG (i.e., HAHA)
  • Radiotherapy: No prior radiotherapy within four weeks of study entry. No prior external beam irradiation to a field that includes more than 30% of the red marrow. No prior radiation to maximal tolerable levels for any critical organ (e.g., 3,000 cGy for the liver; 2,000 cGy for the lungs and kidneys).
  • Other: Any experimental therapy (i.e., drugs, biologics, procedures) for the primary malignancy, either during or within four weeks prior to study entry.

Patient Characteristics/Inclusion Criteria:

  • Performance Status: Patients with a Karnofsky performance status > 70% (or equivalent, ECOG 0-1) and an expected survival rate of at least 3 months
  • Hematopoietic: Hemoglobin > 10g/dL; WBC > 3000 per mm3; Granulocyte count > 1500 per mm3; platelet count > 100,000 per mm3
  • Hepatic: Total bilirubin < 1.5 times the institutional upper limit of normal (IULN); AST or ALT < 2 X IULN
  • Renal: Creatinine < IULN
  • Cardiovascular: Patients with LVEF >/= 50% by required MUGA/2D-ECHO study
  • Pulmonary: Patients with DF and FEV1 >/= 60 % by required Pulmonary Function Tests
  • Gastrointestinal:Patients with severe anorexia or other related symptomology are excluded
  • Central Nervous System: Patient with known metastatic disease to the CNS are excluded
  • Other: Patients who have had a prior imaging study with a murine antibody may be included. Patients agreeing to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be preformed on each premenopausal female of childbearing potential immediately prior to entry into the study. Patients able to understand and give written informed consent.

Trial locations and contacts

10 sites in 4 countries.

10 sites in 4 countries

United States5 sites
  • Hoag Cancer Center

    Newport Beach, California, 92658

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15213

  • Virginia Mason Medical Center

    Seattle, Washington, 98101-2799

  • Bay Pines VA Medical Center

    St. Petersburg, Florida, 33744

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

Germany2 sites
  • Medizinische Fakultaet der Charité Berlin

    Berlin

  • Universitaetsklinikum Leipzig

    Leipzig

Other trials in Germany

Hungary2 sites
  • Semmelweis University

    Budapest

  • Medical University of Szeged

    Szeged

Other trials in Hungary

Netherlands1 site
  • Academic Medical Center

    Amsterdam

Other trials in Netherlands

About this study

Official title: A Phase I/II Study of Radioimmunotherapy With 90Y-Humanized MN-14 IgG Administered as a Single Dose to Patients With Refractory Advanced/Metastatic Pancreatic Carcinoma

The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in the treatment of pancreatic cancer.

Being tested
hMN14 (labetuzumab)
Keywords
Pancreatic Cancer, Pancreatic Carcinoma, Pancreatic Neoplasms, Pancreas Cancer, Pancreatic Tumor
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hMN14 (labetuzumab)Drug

Timeline

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

  1. First posted15 Jul 2002 (estimated)
  2. Study startJan 2000
  3. Study completionDec 2003

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00041639
Sponsor's protocol ID
IM-T-hMN14-03
Status last verified
Jan 2004
First submitted
11 Jul 2002
Last updated
19 Aug 2021
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing hMN14 (labetuzumab) in people with Pancreatic Neoplasms, run by Gilead Sciences at 10 sites in 4 countries.

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 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Germany, Hungary, Netherlands. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 19 Aug 2021.

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