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Pancreatic CancerPhase 1/2NCT00603863

Safety and Efficacy Study of Different Doses of 90Y-hPAM4 Combined With Gemcitabine in Pancreatic Cancer

A Phase 1/2 study testing IMMU-107 (hPAM4) in people with Pancreatic Cancer, run by Gilead Sciences at 11 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

This is a study to test whether different doses of 90Y-hPAM4 are safe to give in combination with gemcitabine in patients with previously untreated pancreatic cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
IMMU-107 (hPAM4)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
11 sitesUnited States
Study dates
Jan 2008to Dec 2013
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

Who may be able to join

  • Male or female patients, >18 years of age, who are able to understand and give written informed consent.
  • Histologically or cytologically confirmed pancreatic adenocarcinoma.
  • Stage III (locally advanced, unresectable) or Stage IV (metastatic) disease, including patients who underwent surgery but had incomplete resections.
  • Treatment naïve (no prior chemotherapy, radiotherapy or investigational agents for pancreatic cancer)
  • Karnofsky performance status > 70 % (Appendix A).
  • Expected survival > 3 months.
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  • At least 4 weeks beyond major surgery and recovered from all acute toxicities
  • At least 2 weeks beyond corticosteroids, except low doses (i.e., 20 mg/day of prednisone or equivalent) to treat nausea or other illness such as rheumatoid arthritis
  • Adequate hematology without ongoing transfusional support (hemoglobin > 11 g/dL, ANC > 2,000 per mm3, platelets > 150,000 per mm3)
  • Adequate renal and hepatic function (creatinine and bilirubin ≤ 1.5 X IULN, AST and ALT ≤ 2.0 X IULN)
  • Otherwise, all toxicity at study entry <Grade 1 by NCI CTC v3.0.

Who cannot join

  • Women who are pregnant or lactating.
  • Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period.
  • Known metastatic disease to the central nervous system.
  • Presence of bulky disease (defined as any single mass >10 cm in its greatest dimension)
  • Patients with >Grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
  • Prior radiation dose >3,000 cGy to the liver, >2,000 cGy to lungs and kidneys or prior external beam irradiation to a field that includes more than 30% of the red marrow.
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  • Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are not excluded, but patients with other prior malignancies must have had at least a 5-year disease free interval.
  • Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
  • Known history of active coronary artery disease, unstable angina, myocardial infarction, or congestive heart failure present within 6 months or cardiac arrhythmia requiring anti-arrhythmia therapy.
  • Known history of active COPD, or other moderate-to-severe respiratory illness present within 6 months.
  • Known autoimmune disease or presence of autoimmune phenomena (except rheumatoid arthritis requiring only low dose maintenance corticosteroids).
  • Infection requiring intravenous antibiotic use within 1 week.
  • Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Winship Cancer Institute/Emory University Hospital

    Atlanta, Georgia, 30322

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Goshen Cancer Center

    Goshen, Indiana, 46526

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Herbert Werthem College of Medicine/Jackson North Medical Center

    Miami, Florida, 33169

  • New York Presbyterian Hospital/Weill Cornell Medical Center

    New York, New York, 10021

  • Mt. Sinai Medical Center

    New York, New York, 10029

  • Christiana Care Health Services

    Newark, Delaware, 19718

  • Thomas Jefferson University Medical Center

    Philadelphia, Pennsylvania, 19107

  • Moffit Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase Ib/II Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Patients With Previously Untreated Advanced Pancreatic Cancer.

This is a study to test whether different doses of 90Y-hPAM4 are safe to give in combination with gemcitabine in patients with previously untreated pancreatic cancer.

Read the detailed description

Patients receive a 4-week treatment cycle with once-weekly 30-minute gemcitabine infusions beginning one week prior to the first 90Y-hPAM4dose and continuing during the 3 consecutive weeks over which once weekly 90Y-hPAM4 doses are given. Depending on toxicity, patient cohorts will receive one of several possible 90Y and gemcitabine dose combinations. Post-treatment evaluations conducted until instituting another 90YhPAM4 treatment cycle, maintenance gemcitabine or for a maximum period of 12 weeks.

Being tested
IMMU-107 (hPAM4)
Keywords
pancreatic cancer, hPAM4, MUC1 antibody, cancer of the pancreas
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • IMMU-107 (hPAM4)Biological

    Also called hPAM4, IMMU-107, 90Y-hPAM4, anti-mucin antibody

    90Y-hPAM4 once weekly for 3 weeks gemcitabine once weekly for 4 weeks

Study groups in NCT00603863
Study groupRoleWhat they receive
multiple dose levelsExperimental1 of 3 different dose levels of 90Y-hPAM4 given once weekly for 3 weeks along with 4 weekly doses of gemcitabine.
Receives: Biological: IMMU-107 (hPAM4)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. safety will be evaluated based upon physical examinations, hematology and chemistry laboratory testing as well as toxicity

    Measured: over 12 weeks

Secondary outcomes (1)

  1. Efficacy and Clinical benefit measures such as quality of life, pain assessments, etc.

    Measured: over 5 years

Timeline

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

  1. First posted29 Jan 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionJul 2013
  4. Study completionDec 2013

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
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00603863
Sponsor's protocol ID
IM-T-hPAM4-02
Status last verified
Jan 2014
First submitted
8 Jan 2008
Last updated
16 Aug 2021
Results posted
No
Data monitoring committee
No

Publications

  • Gold DV, Karanjawala Z, Modrak DE, Goldenberg DM, Hruban RH. PAM4-reactive MUC1 is a biomarker for early pancreatic adenocarcinoma. Clin Cancer Res. 2007 Dec 15;13(24):7380-7. doi: 10.1158/1078-0432.CCR-07-1488.

    PubMed 18094420

  • Modrak DE, Gold DV, Goldenberg DM. Sphingolipid targets in cancer therapy. Mol Cancer Ther. 2006 Feb;5(2):200-8. doi: 10.1158/1535-7163.MCT-05-0420.

    PubMed 16505092

  • Gold DV, Modrak DE, Ying Z, Cardillo TM, Sharkey RM, Goldenberg DM. New MUC1 serum immunoassay differentiates pancreatic cancer from pancreatitis. J Clin Oncol. 2006 Jan 10;24(2):252-8. doi: 10.1200/JCO.2005.02.8282. Epub 2005 Dec 12.

    PubMed 16344318

  • Modrak DE, Cardillo TM, Newsome GA, Goldenberg DM, Gold DV. Synergistic interaction between sphingomyelin and gemcitabine potentiates ceramide-mediated apoptosis in pancreatic cancer. Cancer Res. 2004 Nov 15;64(22):8405-10. doi: 10.1158/0008-5472.CAN-04-2988.

    PubMed 15548711

  • Gold DV, Modrak DE, Schutsky K, Cardillo TM. Combined 90Yttrium-DOTA-labeled PAM4 antibody radioimmunotherapy and gemcitabine radiosensitization for the treatment of a human pancreatic cancer xenograft. Int J Cancer. 2004 Apr 20;109(4):618-26. doi: 10.1002/ijc.20004.

    PubMed 14991585

  • Gold DV, Schutsky K, Modrak D, Cardillo TM. Low-dose radioimmunotherapy ((90)Y-PAM4) combined with gemcitabine for the treatment of experimental pancreatic cancer. Clin Cancer Res. 2003 Sep 1;9(10 Pt 2):3929S-37S.

    PubMed 14506191

  • Modrak DE, Gold DV, Goldenberg DM, Blumenthal RD. Colonic tumor CEA, CSAp and MUC-1 expression following radioimmunotherapy or chemotherapy. Tumour Biol. 2003 Jan-Feb;24(1):32-9. doi: 10.1159/000070658.

    PubMed 12743424

  • Reddy PK, Gold DV, Cardillo TM, Goldenberg DM, Li H, Burton JD. Interferon-gamma upregulates MUC1 expression in haematopoietic and epithelial cancer cell lines, an effect associated with MUC1 mRNA induction. Eur J Cancer. 2003 Feb;39(3):397-404. doi: 10.1016/s0959-8049(02)00700-1.

    PubMed 12565994

  • Cardillo TM, Blumenthal R, Ying Z, Gold DV. Combined gemcitabine and radioimmunotherapy for the treatment of pancreatic cancer. Int J Cancer. 2002 Jan 20;97(3):386-92. doi: 10.1002/ijc.1613.

    PubMed 11774294

  • Cardillo TM, Ying Z, Gold DV. Therapeutic advantage of (90)yttrium- versus (131)iodine-labeled PAM4 antibody in experimental pancreatic cancer. Clin Cancer Res. 2001 Oct;7(10):3186-92.

    PubMed 11595713

  • Gold DV, Cardillo T, Vardi Y, Blumenthal R. Radioimmunotherapy of experimental pancreatic cancer with 131I-labeled monoclonal antibody PAM4. Int J Cancer. 1997 May 16;71(4):660-7. doi: 10.1002/(sici)1097-0215(19970516)71:43.0.co;2-e.

    PubMed 9178823

  • Mariani G, Molea N, Bacciardi D, Boggi U, Fornaciari G, Campani D, Salvadori PA, Giulianotti PC, Mosca F, Gold DV, et al. Initial tumor targeting, biodistribution, and pharmacokinetic evaluation of the monoclonal antibody PAM4 in patients with pancreatic cancer. Cancer Res. 1995 Dec 1;55(23 Suppl):5911s-5915s.

    PubMed 7493369

  • Alisauskus R, Wong GY, Gold DV. Initial studies of monoclonal antibody PAM4 targeting to xenografted orthotopic pancreatic cancer. Cancer Res. 1995 Dec 1;55(23 Suppl):5743s-5748s.

    PubMed 7493339

  • Gold DV, Alisauskas R, Sharkey RM. Targeting of xenografted pancreatic cancer with a new monoclonal antibody, PAM4. Cancer Res. 1995 Mar 1;55(5):1105-10.

    PubMed 7866995

  • Gold DV, Lew K, Maliniak R, Hernandez M, Cardillo T. Characterization of monoclonal antibody PAM4 reactive with a pancreatic cancer mucin. Int J Cancer. 1994 Apr 15;57(2):204-10. doi: 10.1002/ijc.2910570213.

    PubMed 7512537

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IMMU-107 (hPAM4) in people with Pancreatic Cancer, run by Gilead Sciences at 11 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?

The sponsor lists 11 inclusion and 13 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 16 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 11 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 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.

What does the primary outcome measure?

safety will be evaluated based upon physical examinations, hematology and chemistry laboratory testing as well as toxicity (time frame: over 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00603863, which also lists 15 linked publications.

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 16 Aug 2021.

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