- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00668499
A Study of VEGF-Antisense Oligonucleotide in Combination With Pemetrexed and Cisplatin for the Treatment of Advanced Malignant Mesothelioma
A Phase I/II Study of VEGF-Antisense Oligonucleotide (VEGF-AS, Veglin) in Combination With Pemetrexed and Cisplatin for the Treatment of Advanced Malignant Mesothelioma
This will be a single institution non-randomized phase I/II trial for patients with malignant mesothelioma stage II and above, who have not received prior chemotherapy for their disease.
The purpose of this phase is to select a dose of VEGF-AS (antiangiogenesis drug)to be given with standard doses of pemetrexed followed by cisplatin on day 1 of a 21-day cycle.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Study Objectives in Phase I are:
To determine the safety of the combination of VEGF-Antisense Oligonucleotide (VEGF-AS, Veglin™) plus Pemetrexed and Cisplatin in subjects with advanced Malignant Mesothelioma,.via a dose escalation protocol. To determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT) of VEGF-AS plus Premetrexed and Cisplatin. To determine the time to disease progression To determine the objective response rate of the combination of VEGF-AS plus Pemetrexed and Cisplatin for the treatment of advanced malignant mesothelioma
The study Objectives in Phase II are:
To further characterize the toxicity experienced by patients with malignant mesothelioma treated with VEGF-AS plus Cisplatin and Pemetrexed.
To determine median and overall survival.
The Laboratory objectives are:
To measure plasma VEGF levels before, during, and after therapy as a correlate of outcome. To determine the pharmacokinetic profile of VEGF-AS plus Pemetrexed and Cisplatin.
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90033
- USC/Norris Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed malignant pleural mesothelioma, epithelial, sarcomatoid, or mixed subtype
- Patients must have measurable disease,using RECIST criteria.Pleural effusions and ascites are not considered measurable lesions.
- Patients with pleural mesothelioma must be IMIG stage ≥II
- Age greater than or equal to 18 years.
- ECOG performance status less than or equal to 2 and an estimated survival of at least 3 months
- Patients must have adequate organ and marrow function as defined below:
Absolute neutrophil count greater than or equal to1,500 Platelets greater than or equal to 100,000 Total bilirubin less than or equal to2.0x the upper limits of institutional normal AST/ALT less than or equal to 2.0x the upper limits of institutional normal Creatinine Clearance greater than 50ml/min
- The effects of VEGF-AS on the developing human fetus are unknown.
- Pemetrexed may cause fetal harm when administered to a pregnant woman and is classified pregnancy category D. There are no studies of pemetrexed in pregnant women. Cisplatin is also categorized as FDA Pregnancy Category D. There is positive evidence of human fetal risk. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent.
- Patients with history of prior cured malignancy > 5 years since the completion of treatment may be accrued provided that other eligibility criteria are met.
Exclusion Criteria:
- Patients who have had chemotherapy for Mesothelioma prior to study entry
- Patients who have had radiation therapy within 3 weeks prior to entering the study. All patients should have recovered from all toxicities of prior therapy.
- Patients receiving therapy with other investigational agents at the time of study enrollment.
- Patients with uncontrolled brain metastases
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant and nursing women are excluded from this study
- Patients who had any major surgery within 4 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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The primary endpoint of the phase II trial will be time to progression
Time Frame: Tumor measurements every 6 weeks
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Tumor measurements every 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary endpoints are objective response rate and overall survival
Time Frame: Every 6 weeks evaluations
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Every 6 weeks evaluations
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Barbara Gitlitz, MD, University of Southern California
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Mesothelioma
- Mesothelioma, Malignant
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Folic Acid Antagonists
- Cisplatin
- Pemetrexed
Other Study ID Numbers
- 18M-07-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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