Study of Anti-Mesothelin Immunotoxin in Advanced Malignancies
Study of SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin in Advanced Malignancies:
IV Infusion QOD x Six Doses
Background:
SS1(dsFv)-PE38 is an oncology drug product containing a bacteria toxin, fused to
a high affinity, disulfide stabilized antibody. The fused protein retains cell killing
activity, but binds only to cells expressing mesothelin. Tumors characterized by
very high surface mesothelin expression include mesothelioma; epithelial carcinomas
of ovary and peritoneum; and squamous cancers of cervix and upper aerodigestive
tract, including esophagus, head, and neck cancers.
This is a dose-escalating study to determine the maximum tolerated dose (MTD) of
intravenous SS1(dsFv)-PE38 administered once every other day for six doses. Dose
escalation will proceed in cohorts of 3 until dose-limiting toxicity (DLT) is observed.
Location and Contact Information:
Joyce Steinberg, M.D. 847-295-8678
jsteinberg@neophrm.com
Amy Grahn, M.S 847-295-8678
agrahn@neophrm.com
Maryland
NCI/NIH, Bethesda, Maryland, 73104, United States; Recruiting
Raffit Hassan, M.D. 301-451-8742 hassan@mail.nih.gov
Raffit Hassan, M.D., Principal Investigator
Background:
Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
Tumor cells. This is a Phase I trial to study the effectiveness of combination chemotherapy
in treating patients who have advanced lung cancer or esophageal cancer that cannot
be removed by surgery.
Maryland
Bethesda
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Patient Recruitment
Ph: 301-496-4891
1-888-NCI-1937
