| Continuation Study of Monoclonal Antibody ABX-EGF (MOAB ABX-EGF) in Patients With Metastatic Renal Cell Carcinoma That Stabilized or Responded to Prior MOAB ABX-EGF Therapy
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information
Alternate Title
Continued Use of Monoclonal Antibody ABX-EGF in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer)
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| No phase specified | Treatment | Closed | 18 and over | UCLA-0311047
ABX-0311, NCT00081185 |
Objectives Primary - Provide continued treatment with monoclonal antibody ABX-EGF (MOAB ABX-EGF) to patients with metastatic renal cell carcinoma who have tolerated and benefited from prior treatment with MOAB ABX-EGF.
Secondary - Determine the long-term safety of this drug in these patients.
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy:
Biologic therapy - See Disease Characteristics
- No other prior anti-epidermal growth factor receptor agents
- No other concurrent anti-epidermal growth factor receptor agents
Chemotherapy - Concurrent chemotherapy allowed
Endocrine therapy - Concurrent hormonal therapy allowed
- Concurrent steroid therapy allowed provided it is used only as replacement therapy
Radiotherapy Surgery Other - No other prior investigational drugs between the last visit of the prior ABX-EGF study and the initial visit of this study
- No concurrent antihypercalcemic treatment as cancer therapy for bone disease
- Antihypercalcemic treatment allowed for elevated calcium levels
- No other concurrent investigational drugs (except during the long-term survival follow-up period of this study)
- Concurrent standard cancer therapy is allowed during the safety and long-term survival follow-up periods of this study
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic Hepatic Renal - No hypercalcemia (i.e., calcium > upper limit of normal)
Cardiovascular - LVEF ≥ 45% by MUGA
- Current LVEF must be within 10% of the baseline LVEF on the prior ABX-EGF study
- No myocardial infarction within the past year
Other - HIV negative
- No allergy to any ingredient in the study drug
- No allergy to Staphylococcus aureus protein A
- No other active malignancy requiring treatment within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix
- No prior chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 month after study participation
Expected Enrollment Not specified. Outline This is an open-label, extension study. Patients receive monoclonal antibody ABX-EGF IV over 1 hour once weekly for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks and then every 3 months for 1 year.
Trial Contact Information
Trial Lead Organizations Jonsson Comprehensive Cancer Center at UCLA  | | | | Robert Figlin, MD, FACP, Principal investigator(Contact information may not be current) | | | Ph: 310-825-5268; 888-798-0719 |
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Related Information PDQ® clinical trial UCLA-9906078
| Registry Information | | | Official Title | | A Multicenter, Open-Label Clinical Trial to Determine the Safety of ABX-EGF as Continued Treatment for Patients Who Have Benefited from and Tolerated Prior ABX-EGF Treatment | | | Trial Start Date | | 2004-04-30 | | | Registered in ClinicalTrials.gov | | NCT00081185 | | | Date Submitted to PDQ | | 2004-02-23 | | | Information Last Verified | | 2004-10-29 | | | NCI Grant/Contract Number | | CA16042 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
