ABT-510 in Treating Patients With Locally Recurrent or Metastatic Renal Cell (Kidney) Cancer
This study is no longer recruiting patients.
Sponsored by: |
Jonsson Comprehensive Cancer Center
|
Information provided by: |
National Cancer Institute (NCI) |
Purpose
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
|
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Kidney Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Randomized Study of ABT-510 in Patients With Locally Recurrent or Metastatic Renal Cell Cancer
Further Study Details:
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.
Eligibility
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
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
Performance status
Life expectancy
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
Location
Information
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
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000355120; UCLA-0308112; ABBOTT-M02-428
Record last reviewed:
October 2004
Record first received:
April 7, 2004
ClinicalTrials.gov Identifier:
NCT00080704Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-22