Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT01413451
Status:
TERMINATED
Last Update Posted:
2019-12-17
First Post:
2011-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Amatuximab for High Mesothelin Cancers
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers
Status:
TERMINATED
Status Verified Date:
2013-11-15
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background:
\- Amatuximab is a cancer treatment drug that targets mesothelin. High levels of this substance are found on some kinds of tumor cells. Lab studies have shown that amatuximab helps the immune system to kill cells that have high levels of mesothelin. However, more research is needed to determine how safe and effective amatuximab is for treating tumors with high levels of mesothelin.
Objectives:
\- To assess the safety and effectiveness of amatuximab in treating tumors with high levels of mesothelin.
Eligibility:
\- Individuals at least 18 years of age who have a type of cancer that overexpresses mesothelin.
Design:
* Participants will be screened with a medical history and physical exam. They will also have blood tests and tumor assessment studies.
* Participants will have two intravenous doses of amatuximab several hours apart. Researchers will monitor them closely and do frequent blood draws. On the same day and also within 48 hours of the second dose, participants will have imaging studies. These studies will measure how well the amatuximab is working against the cancer.
* Participants will have a third imaging study of the cancer about 1 week after the infusions.
* Participants will have a followup visit 2 weeks after receiving amatuximab. This visit will require blood samples. Four weeks after receiving the drug, researchers will review patients symptoms or side effects. This interview can be done in person or by phone.
\- Amatuximab is a cancer treatment drug that targets mesothelin. High levels of this substance are found on some kinds of tumor cells. Lab studies have shown that amatuximab helps the immune system to kill cells that have high levels of mesothelin. However, more research is needed to determine how safe and effective amatuximab is for treating tumors with high levels of mesothelin.
Objectives:
\- To assess the safety and effectiveness of amatuximab in treating tumors with high levels of mesothelin.
Eligibility:
\- Individuals at least 18 years of age who have a type of cancer that overexpresses mesothelin.
Design:
* Participants will be screened with a medical history and physical exam. They will also have blood tests and tumor assessment studies.
* Participants will have two intravenous doses of amatuximab several hours apart. Researchers will monitor them closely and do frequent blood draws. On the same day and also within 48 hours of the second dose, participants will have imaging studies. These studies will measure how well the amatuximab is working against the cancer.
* Participants will have a third imaging study of the cancer about 1 week after the infusions.
* Participants will have a followup visit 2 weeks after receiving amatuximab. This visit will require blood samples. Four weeks after receiving the drug, researchers will review patients symptoms or side effects. This interview can be done in person or by phone.
Detailed Description:
Background:
* Amatuximab is a high-affinity monoclonal IgG antibody raised against human mesothelin.
* Mesothelin is a glycosyl-phosphatidyl inositol-linked membrane glycoprotein thought to be involved in tumor metastasis
* Mesothelin is over-expressed in many cancers
Objectives:
-The primary objective is to determine the biodistribution of radiolabeled amatuximab in tumor and nontumor tissues in subjects with mesothelin over-expressing cancers including mesothelioma, pancreatic, ovarian, and non small cell lung cancer.
Eligibility:
* Female or male subjects greater than or equal to 18 years of age;
* Histologically confirmed mesothelin-expressing cancer;
* Transaminases less than or equal to 3 times ULN for mesothelioma, non small cell lung and ovarian cancer;
* Transaminases less than or equal to 5 times ULN for pancreatic cancer with known liver metastasis.
Design:
* This is a single-center, single-dose, open-label, pilot study of MORAb-009 in approximately 20 subjects with mesothelin expressing tumors.
* Indium-radiolabeled MORAb-009 (5mCi) will be administered.
* Serial single photon emission-computerized tomography imaging will be performed to determine binding to tumor and nontumor tissue.
* Subjects will be observed closely for safety and possible development of anti-MORAb-009 antibodies.
* Pharmacokinetics of radiolabeled antibody will be determined with imaging over time.
* Amatuximab is a high-affinity monoclonal IgG antibody raised against human mesothelin.
* Mesothelin is a glycosyl-phosphatidyl inositol-linked membrane glycoprotein thought to be involved in tumor metastasis
* Mesothelin is over-expressed in many cancers
Objectives:
-The primary objective is to determine the biodistribution of radiolabeled amatuximab in tumor and nontumor tissues in subjects with mesothelin over-expressing cancers including mesothelioma, pancreatic, ovarian, and non small cell lung cancer.
Eligibility:
* Female or male subjects greater than or equal to 18 years of age;
* Histologically confirmed mesothelin-expressing cancer;
* Transaminases less than or equal to 3 times ULN for mesothelioma, non small cell lung and ovarian cancer;
* Transaminases less than or equal to 5 times ULN for pancreatic cancer with known liver metastasis.
Design:
* This is a single-center, single-dose, open-label, pilot study of MORAb-009 in approximately 20 subjects with mesothelin expressing tumors.
* Indium-radiolabeled MORAb-009 (5mCi) will be administered.
* Serial single photon emission-computerized tomography imaging will be performed to determine binding to tumor and nontumor tissue.
* Subjects will be observed closely for safety and possible development of anti-MORAb-009 antibodies.
* Pharmacokinetics of radiolabeled antibody will be determined with imaging over time.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 11-C-0212 | None | None | View |