RATIONALE: ABT-510 may stop the growth of renal cell (kidney) cancer by stopping blood flow to the tumor.

PURPOSE: Randomizedphase II trial to study the effectiveness of ABT-510 in treating patients who have locallyrecurrent or metastatic renal cell cancer.

Condition	Treatment or Intervention	Phase
recurrent renal cell cancer stage III renal cell cancer Stage IV Renal Cell Cancer	Drug: ABT-510  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Procedure: biological response modifier therapy  Procedure: growth factor antagonist therapy	Phase II

OBJECTIVES: Primary

• Determine the safety of ABT-510, administered in 2 different doses, in patients with locally recurrent or metastatic renal cell cancer.
• Determine the efficacy of this drug, at 2 different doses, in terms of progression-free survival, in these patients.

Secondary

• Determine the response rate, performance status, and overall survival of patients treated with this drug at 2 different doses.

OUTLINE: This is a randomized, open-label, parallel-group, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive ABT-510 subcutaneously (SC) twice daily on days 1-28.
• Arm II: Patients receive a higher dose of ABT-510 SC twice daily on days 1-28. Courses in both arms repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 30 days and then every 3 months for up to 2 years.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed renal cell cancer
• Locally recurrent or metastatic disease
• Measurable disease
• At least 1 unidimensionally measurable lesion
• At least 10 mm by spiral CT scan OR at least 20 mm by conventional CT scan
• Not amenable to curative resection
• No know CNS metastasis
• Previously treated brain metastases allowed provided no evidence of disease is observed on MRI within the past 28 days

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Hemoglobin ≥ 9.0 g/dL
• Platelet count ≥ 100,000/mm^3
• WBC ≥ 3,000/mm^3

Hepatic

• AST and ALT ≤ 1.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
• Albumin ≥ 3.0 g/dL
• Bilirubin ≤ 1.5 mg/dL
• Lactate dehydrogenase ≤ 1.5 times ULN

Renal

• Creatinine ≤ 2.0 mg/dL
• Calcium ≤ 10 mg/dL

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 12 weeks after study participation
• Able to self-administer or has a caregiver who can administer subcutaneous injections
• Able to tolerate proposed study treatment or procedures
• No other clinically significant uncontrolled condition that would preclude study participation
• No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy

• No prior immunotherapy for metastatic renal cell cancer
• No concurrent immunotherapy

Chemotherapy

• No prior chemotherapy for metastatic renal cell cancer
• No concurrent cytotoxic chemotherapy

Endocrine therapy

• No prior hormonal therapy for metastatic renal cell cancer

Radiotherapy

• No prior antitumor radiotherapy for metastatic renal cell cancer
• No concurrent radiotherapy
• Concurrent supportive local radiotherapy involving a small radiation field allowed except within 28 days of day 1 of course 1 of study treatment

Surgery

• Prior excision of primary tumor, where appropriate, allowed
• No concurrent surgery

Other

• No prior investigational therapy for metastatic renal cell cancer
• No other prior therapy for metastatic renal cell cancer
• No concurrent therapeutic anticoagulation therapy
• Concurrent low-dose anticoagulation therapy for catheter prophylaxis is allowed provided PT/PTT are within normal limits
• No other concurrent investigational therapy
• No other concurrent antineoplastic agents

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-5907,  United States

Study chairs or principal investigators

Robert Alan Figlin, MD, FACP,  Principal Investigator,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000355120; UCLA-0308112; ABBOTT-M02-428
Record last reviewed:  October 2004
Record first received:  April 7, 2004
ClinicalTrials.gov Identifier:  NCT00080704
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-22