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EMD 121974 in Treating Patients With Locally Advanced or Metastatic Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Indiana University Identifier:
First received: January 28, 2000
Last updated: September 16, 2014
Last verified: September 2014

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.

Condition Intervention Phase
Chronic Myeloproliferative Disorders
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 Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of escalating doses of twice weekly EMD 121974 in patients with cancer. [ Time Frame: enrollement through termination ]

Estimated Enrollment: 40
Study Start Date: December 1999
Study Completion Date: September 2001
Primary Completion Date: August 2001 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: cilengitide
    dose escalation of cilengitide
Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced or metastatic cancer that is considered incurable and for which no standard curative therapy exists No primary CNS malignancies Measurable evidence of residual, recurrent, or metastatic disease No prior CNS metastases with residual abnormal findings on neuroradiologic studies Prior CNS metastases allowed provided at least 6 months from definitive therapy and a normal CT or MRI of the brain

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Hemoglobin at least 9 mg/dL (may be post transfusion) Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal SGOT/SGPT no greater than 2.5 times upper limit of normal PT/PTT normal Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection requiring parenteral antibiotics No documented abnormal CNS exam with seizure disorder or major neuropsychiatric problems

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior hematopoietic growth factor or cytokine therapy and recovered No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (at least 6 weeks since prior nitrosoureas or mitomycin) and recovered No concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids except for steroid replacement therapy or chronic low dose (no greater than 10 mg/day oral prednisone) therapy for nonmalignant conditions No concurrent hormonal therapy except oral contraceptives or hormonal replacement therapy Radiotherapy: At least 2 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: At least 2 weeks since prior surgery and recovered Other: At least 4 weeks since other prior investigational drugs No concurrent oral or parenteral anticoagulants except anticoagulants for central venous catheters including low dose warfarin (1-2 mg/day) and/or heparin No concurrent oral COX-2 specific inhibitors (e.g., celecoxib or rofecoxib)

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Please refer to this study by its identifier: NCT00004258

United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5265
Sponsors and Collaborators
Indiana University School of Medicine
National Cancer Institute (NCI)
Study Chair: Michael S. Gordon, MD Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
  More Information

Responsible Party: George Sledge, MD/ Principal Investigator, Indiana University School of Medicine Identifier: NCT00004258     History of Changes
Other Study ID Numbers: 9909-40; T99-0076
Study First Received: January 28, 2000
Last Updated: September 16, 2014

Keywords provided by Indiana University:
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
monoclonal gammopathy of undetermined significance
recurrent adult Hodgkin lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
isolated plasmacytoma of bone
extramedullary plasmacytoma
refractory multiple myeloma
Waldenstrom macroglobulinemia
stage III multiple myeloma
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
small intestine lymphoma
unspecified adult solid tumor, protocol specific
chronic phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid leukemia
polycythemia vera
essential thrombocythemia
untreated hairy cell leukemia

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Neoplasm Metastasis
Myeloproliferative Disorders
Intestinal Neoplasms
Precancerous Conditions
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Neoplastic Processes
Gastrointestinal Neoplasms processed this record on April 28, 2017