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 Sponsor Protocol IDs No phase specified Treatment Closed 18 and over NCI, Pharmaceutical / Industry UCLA-0311047 ABX-0311, NCT00081185

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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