Clinical Trial: EMD 121974 in Treating Patients With Locally Advanced or Metastatic Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase I Trial of EMD 121974 in Patients With Advanced or Metastatic Cancer
Brief Summary:
RATIONALE: EMD 121974 may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of EMD 121974 in treating patients who have locally advanced or metastatic cancer.
Detailed Summary:
OBJECTIVES: I. Determine the safety and tolerability of EMD 121974 in patients with advanced or metastatic cancer. II. Correlate various surrogate markers of antiangiogenic activity with EMD 121974 therapy including magnetic resonance imaging and PET scans, serum assays for various angiogenic and antiangiogenic factors, serum and urine markers of calcium metabolism, and tumor biopsies.
OUTLINE: This is a dose-escalation study. Patients receive EMD 121974 IV over 1 hour twice weekly for 4 weeks. Treatment continues for an additional course in the absence of unacceptable toxicity. Patients with stable or responding disease may continue therapy indefinitely past the 2 courses until disease progression. Cohorts of 3-6 patients receive escalating doses of EMD 121974 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities. Patients are followed every 3 months for the first year, and then every 4 months thereafter until disease progression.
PROJECTED ACCRUAL: A total of 31-40 patients will be accrued for this study.
Sponsor: Indiana University School of Medicine
Current Primary Outcome: To evaluate the safety and tolerability of escalating doses of twice weekly EMD 121974 in patients with cancer. [ Time Frame: enrollement through termination ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Indiana University
Dates:
Date Received: January 28, 2000
Date Started: December 1999
Date Completion:
Last Updated: September 16, 2014
Last Verified: September 2014
