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ABT-510 in Treating Patients With Locally Recurrent or Metastatic Renal Cell (Kidney) Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00080704
  Purpose

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

PURPOSE: Randomized phase II trial to study the effectiveness of ABT-510 in treating patients who have locally recurrent or metastatic renal cell cancer.


Condition Intervention Phase
Kidney Cancer
Drug: ABT-510
Phase II

MedlinePlus related topics: Cancer Kidney Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
Official Title: A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects With Advanced Renal Cell Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2003
Detailed Description:

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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00080704

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-5907
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Robert A. Figlin, MD, FACP Jonsson Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000355120, UCLA-0308112, ABBOTT-M02-428
Study First Received: April 7, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00080704  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer

Study placed in the following topic categories:
Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Recurrence
Carcinoma
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009