EMD 121974 in Treating Patients With Locally Advanced or Metastatic Cancer
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.
|Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Precancerous/Nonmalignant Condition Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific||Drug: cilengitide||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of EMD 121974 in Patients With Advanced or Metastatic Cancer|
- To evaluate the safety and tolerability of escalating doses of twice weekly EMD 121974 in patients with cancer. [ Time Frame: enrollement through termination ]
|Study Start Date:||December 1999|
|Study Completion Date:||September 2001|
|Primary Completion Date:||August 2001 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004258
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202-5265|
|Study Chair:||Michael S. Gordon, MD||Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea|