RAV12 in Treating Patients With Metastatic or Recurrent Adenocarcinoma
- Conditions
- Cancer
- Interventions
- Biological: monoclonal antibody RAV12
- Registration Number
- NCT00101972
- Lead Sponsor
- MacroGenics
- Brief Summary
RATIONALE: Monoclonal antibodies, such as RAV12, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase I trial is studying the side effects and best dose of RAV12 in treating patients with metastatic or recurrent adenocarcinoma.
- Detailed Description
OBJECTIVES:
* Determine the maximum tolerated dose of RAV12 in patients with metastatic or recurrent adenocarcinoma.
* Determine the toxicity profile of this drug in these patients.
* Determine the pharmacokinetics and immunogenicity of this drug in these patients.
* Determine, preliminarily, the antitumor activity of this drug in these patients.
OUTLINE: This is an open-label, dose-escalation study.
Patients receive RAV12 IV over 2 hours 2-3 times per week in weeks 1-4 (course 1). Patients are evaluated for response on day 43. Patients achieving a partial or complete response may be eligible to receive additional courses of RAV12 as above. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of RAV12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Up to 15 additional patients are treated at the MTD in 1 or more patients groups (e.g., colorectal, pancreatic, gastroesophageal, and other adenocarcinoma).
After completion of study treatment, patients are followed within 4 weeks and then every 6-12 months thereafter.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RAV12 monoclonal antibody RAV12 -
- Primary Outcome Measures
Name Time Method Toxicity by CTCAE Days 1-50
- Secondary Outcome Measures
Name Time Method Maximum tolerated dose Days 1-50 Pharmacokinetics of RAV12 by serum levels Days 1, 2, 4, 5, 8, 15, 22, 29, 36, 43, and 50 Immunogenicity by Human Anti-chimeric antibodies Days 1, 8, 15, 22, and 50 Progression free survival by clinical assessment 3 and 6 months Time to tumor progression by clinical assessment 6 months
Trial Locations
- Locations (5)
University of Miami Sylvester Comprehensive Cancer Center - Miami
🇺🇸Miami, Florida, United States
Premiere Oncology
🇺🇸Santa Monica, California, United States
Fox Chase Cancer Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Sarah Cannon Cancer Center at Centennial Medical Center
🇺🇸Nashville, Tennessee, United States