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Mesothelioma

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