Status:
WITHDRAWN
A Study of VEGF-Antisense Oligonucleotide in Combination With Pemetrexed and Cisplatin for the Treatment of Advanced Malignant Mesothelioma
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
Sponsor Name Pending
Conditions:
Mesothelioma
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00668499
Start Date
April 1 2008
End Date
April 1 2011
Last Update
May 21 2014
Active Locations (1)
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1
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033