Solid Tumor
A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers
NCI-11-C-0212, NCT01413451
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Investigator(s): |
Raffit Hassan, M.D. Principal Investigator Phone: 301-451-8742
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Yvonne Mallory, R.N., B.S.N. Research Nurse Phone: 301-402-0255 malloryy@mail.nih.gov
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Jeannette Nashed, C.R.N.P. Nurse Practitioner Phone: 301-594-1827 Jeannette.nashed@nih.gov
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Key Eligibility Criteria:
- Histologically confirmed diagnosis of pancreatic adenocarcinoma, mesothelioma, mesothelin-positive ovarian cancer, or non-small cell lung cancer
- Has received appropriate prior therapy
- Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
- ≥ 18 years of age
- ECOG ≤ 2
- Adequate hematologic, renal, and hepatic function
- No uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
- No previous treatment with amatuximab or SS1(dsFv)PE38 (SS1P)
- Not pregnant or breast feeding
Study Outline:
- Screening physical examination; blood and tumor samples; and imaging studies to determine eligibility for the study
- Amatuximab is given as an intravenous infusion (through a vein)
- Close monitoring with frequent blood draws
- Imaging studies on the same day and also within 48 hours of receiving amatuximab
- Third imaging study about 1 week later
- Follow-up clinic visit 2 weeks after receiving amatuximab
- Phone or clinic follow-up interview 4 weeks after receiving amatuximab
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 9/11/12
Updated: 10/11/12