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

Objectives

Primary

1. 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

1. Determine the long-term safety of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Diagnosis of renal cell carcinoma
  • Metastatic disease
• Received and tolerated prior treatment with monoclonal antibody ABX-EGF while enrolled on 1 of the following studies:
  • ABX-EGF-0303
  • ABX-EGF-9901
  • ABX-EGF-9902
• Stable or responding disease at the final treatment visit* of the prior ABX-EGF study AND at the initial visit of this study

   [Note: *Final treatment visit was within the past 2 months]

• No uncontrolled or symptomatic brain metastases

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

• Not specified

Surgery

• Not specified

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

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

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

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

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