A Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Pancreatic Cancer Patients Receiving at Least 2 Prior Therapies.



Status:Completed
Conditions:Cancer, Cancer, Cancer, Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:March 2012
End Date:March 2015
Contact:Michael Sosnowski
Email:msosnowski@immunomedics.com
Phone:973-605-8200

Use our guide to learn which trials are right for you!

A Ph Ib Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Pancreatic Cancer Patients Receiving at Least 2 Prior Therapies.


90Y-hPAM4 is administered weekly for 3 weeks combined with 4 weekly doses of gemcitabine to
assess. This is a dose escalation study of 90Y-hPAM4 to assess which dose is safe and
effective as 3rd line treatment for patients with metastatic pancreatic cancer. Patients are
then followed weekly for 12 weeks and afterwards for up to 1 year.


Inclusion Criteria:

- 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 IV (metastatic) disease, including patients who underwent surgery but had
incomplete resections

- Previously treated and received two prior treatment regimens for advanced disease

- Karnofsky performance status ≥ 60 % (Appendix A)

- Expected survival ≥ 3 months

- At least 4 weeks beyond major surgery, 2 weeks beyond chemotherapy, radiotherapy,
other experimental treatments

- 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 > 9 g/dL, ANC >
1,500 per mm3, platelets > 100,000 per mm3)

- Adequate renal and hepatic function (creatinine and bilirubin ≤ 1.5 X IULN, AST and
ALT ≤ 2.0 X IULN [5.0 X IULN if due to liver metastases])

- Otherwise, all toxicity at study entry ≤ Grade 1 by NCI CTC v3.0 or recovered to
baseline or discussed with and agreed to with Immunomedics' Medical Monitor.

Exclusion Criteria:

- 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 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

- 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 3-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 (other than stable atrial fibrillation) 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
We found this trial at
24
sites
New York, New York 10029
480
mi
from 43215
New York, NY
Click here to add this to my saved trials
1365 Clifton Road Northeast
Atlanta, Georgia 30322
432
mi
from 43215
Atlanta, GA
Click here to add this to my saved trials
100 E. Idaho St.
Boise City, Idaho 83712
208-381-2711
1715
mi
from 43215
Boise City, ID
Click here to add this to my saved trials
12902 Usf Magnolia Drive
Tampa, Florida 33612
(888) 663-3488
Moffitt Cancer Center Moffitt Cancer Center in Tampa, Florida, has made a lasting commitment to...
822
mi
from 43215
Tampa, FL
Click here to add this to my saved trials
Albuquerque, New Mexico 87109
1327
mi
from 43215
Albuquerque, NM
Click here to add this to my saved trials
Chapel Hill, North Carolina
353
mi
from 43215
Chapel Hill, NC
Click here to add this to my saved trials
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
1
mi
from 43215
Columbus, OH
Click here to add this to my saved trials
Gilbert, Arizona 85234
1651
mi
from 43215
Gilbert, AZ
Click here to add this to my saved trials
Goshen, Indiana 46526
184
mi
from 43215
Goshen, IN
Click here to add this to my saved trials
Grand Rapids, Michigan 49503
247
mi
from 43215
Grand Rapids, MI
Click here to add this to my saved trials
Greenville, South Carolina 29605
358
mi
from 43215
Greenville, SC
Click here to add this to my saved trials
Miami, Florida 33169
996
mi
from 43215
Miami, FL
Click here to add this to my saved trials
996
mi
from 43215
Miami, FL
Click here to add this to my saved trials
New York, New York 10021
477
mi
from 43215
New York, NY
Click here to add this to my saved trials
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
480
mi
from 43215
New York, NY
Click here to add this to my saved trials
385
mi
from 43215
Newark, DE
Click here to add this to my saved trials
Norfolk, Virginia 23502
423
mi
from 43215
Norfolk, VA
Click here to add this to my saved trials
Novi, Michigan 48337
174
mi
from 43215
Novi, MI
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19107
416
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
333 Cottman Ave
Philadephia, Pennsylvania 19111
(215) 728-6900
Fox Chase Cancer Center Fox Chase has earned the prestigious designation from the National Cancer...
420
mi
from 43215
Philadephia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15232
166
mi
from 43215
Pittsburgh, PA
Click here to add this to my saved trials
Scottsdale, Arizona 85259
1645
mi
from 43215
Scottsdale, AZ
Click here to add this to my saved trials
Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
2007
mi
from 43215
Seattle, WA
Click here to add this to my saved trials
Tyler, Texas 75702
862
mi
from 43215
Tyler, TX
Click here to add this to my saved trials