Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT01160458
Status:
COMPLETED
Last Update Posted:
2018-04-10
First Post:
2010-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Phase II Study of IMC-A12 in Patients With Mesothelioma Who Have Been Previously Treated With Chemotherapy
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Phase II Study of IMC-A12 in Patients With Mesothelioma Who Have Been Previously Treated With Chemotherapy
Status:
COMPLETED
Status Verified Date:
2018-03
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:
Background:
\- IMC-A12, a new cancer treatment that has not yet been approved by the U.S. Food and Drug Administration, is an antibody that is designed to block the effects of a protein called Type I Insulin-Like Growth Factor (IGF-1R). IMC-A12 blocks the receptors in cells that respond to IGF-1R, which are thought to play an important role in helping cancer cells to grow and divide. Researchers are interested in determining whether IMC-A12 is an effective treatment for individuals who have mesothelioma that has not responded to standard chemotherapy.
Objectives:
\- To evaluate the safety and effectiveness of IMC-A12 treatment in individuals with mesothelioma who have previously had chemotherapy.
Eligibility:
\- Individuals at least 18 years of age who have been diagnosed with mesothelioma that has not responded to chemotherapy.
Design:
* Eligible participants will be screened with a full physical examination and medical history, blood and urine samples, and imaging studies.
* Participants will receive IMC-A12 once every 3 weeks (21-day cycle), and will be evaluated before the start of each new cycle with blood tests and imaging studies if needed.
* Treatment cycles will continue for as long as needed, unless severe side effects develop or the disease progresses.
Background:
\- IMC-A12, a new cancer treatment that has not yet been approved by the U.S. Food and Drug Administration, is an antibody that is designed to block the effects of a protein called Type I Insulin-Like Growth Factor (IGF-1R). IMC-A12 blocks the receptors in cells that respond to IGF-1R, which are thought to play an important role in helping cancer cells to grow and divide. Researchers are interested in determining whether IMC-A12 is an effective treatment for individuals who have mesothelioma that has not responded to standard chemotherapy.
Objectives:
\- To evaluate the safety and effectiveness of IMC-A12 treatment in individuals with mesothelioma who have previously had chemotherapy.
Eligibility:
\- Individuals at least 18 years of age who have been diagnosed with mesothelioma that has not responded to chemotherapy.
Design:
* Eligible participants will be screened with a full physical examination and medical history, blood and urine samples, and imaging studies.
* Participants will receive IMC-A12 once every 3 weeks (21-day cycle), and will be evaluated before the start of each new cycle with blood tests and imaging studies if needed.
* Treatment cycles will continue for as long as needed, unless severe side effects develop or the disease progresses.
Detailed Description:
Background:
Platinum-based chemotherapy is the standard of care for advanced unresectable malignant mesothelioma. New options for treatment are necessary in patients with advanced disease that have progressed on platinum-based therapy. The insulin-like growth factor (IGF) pathway is being studies in various malignancies including mesothelioma. IMC-A12 is an anti-IGF-1R monoclonal antibody that has shown activity in patients with various malignancies.
Objectives:
Primary Objective:
\- To determine the clinical response rate (partial response (PR)+complete response (CR)) to IMC-A12 monotherapy in patients with advanced mesothelioma.
Secondary Objectives:
* To determine response duration, progression free survival (PFS) and overall survival (OS).
* To assess safety of IMC-A12 in patients with mesothelioma
Exploratory Objectives:
* To evaluate tumor IGF-1R expression and correlation with response
* To correlate response to therapy with changes in fludeoxyglucose 18F-positron emission tomography (FDG-PET) imaging.
* To monitor serum mesothelin and cancer antigen 125 or carbohydrate antigen 125 (CA-125) levels prior to and during therapy.
Eligibility:
* Patients with histologically confirmed malignant pleural or peritoneal mesothelioma who have previously been treated on at least one platinum-containing chemotherapy regimen with progressive disease documented prior to study entry, or have refused cytotoxic chemotherapy.
* Measurable disease by modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for pleural mesothelioma or by RECIST criteria for peritoneal mesothelioma.
* Adequate renal, hepatic and hematopoietic function.
* No major surgery, radiotherapy, chemotherapy or biologic therapy within 28 days of IMC-A12 therapy
Design:
* Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks.
* Treatment with IMC-A12 alone will continue until disease progression.
* Toxicity will be assessed every cycle by the Cancer Therapy Evaluation Program (CTEP) Version 4.0 of Common Terminology Criteria for Adverse Events (CTCAE).
* Tumor response assessments will be performed every 2 cycles.
Platinum-based chemotherapy is the standard of care for advanced unresectable malignant mesothelioma. New options for treatment are necessary in patients with advanced disease that have progressed on platinum-based therapy. The insulin-like growth factor (IGF) pathway is being studies in various malignancies including mesothelioma. IMC-A12 is an anti-IGF-1R monoclonal antibody that has shown activity in patients with various malignancies.
Objectives:
Primary Objective:
\- To determine the clinical response rate (partial response (PR)+complete response (CR)) to IMC-A12 monotherapy in patients with advanced mesothelioma.
Secondary Objectives:
* To determine response duration, progression free survival (PFS) and overall survival (OS).
* To assess safety of IMC-A12 in patients with mesothelioma
Exploratory Objectives:
* To evaluate tumor IGF-1R expression and correlation with response
* To correlate response to therapy with changes in fludeoxyglucose 18F-positron emission tomography (FDG-PET) imaging.
* To monitor serum mesothelin and cancer antigen 125 or carbohydrate antigen 125 (CA-125) levels prior to and during therapy.
Eligibility:
* Patients with histologically confirmed malignant pleural or peritoneal mesothelioma who have previously been treated on at least one platinum-containing chemotherapy regimen with progressive disease documented prior to study entry, or have refused cytotoxic chemotherapy.
* Measurable disease by modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for pleural mesothelioma or by RECIST criteria for peritoneal mesothelioma.
* Adequate renal, hepatic and hematopoietic function.
* No major surgery, radiotherapy, chemotherapy or biologic therapy within 28 days of IMC-A12 therapy
Design:
* Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks.
* Treatment with IMC-A12 alone will continue until disease progression.
* Toxicity will be assessed every cycle by the Cancer Therapy Evaluation Program (CTEP) Version 4.0 of Common Terminology Criteria for Adverse Events (CTCAE).
* Tumor response assessments will be performed every 2 cycles.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 10-C-0146 | None | None | View |