Purpose

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
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: cilengitide
Phase I

Genetics Home Reference related topics:   Benign Tumors   Bone Marrow Diseases   Cancer  

MedlinePlus related topics:   Cancer   Hodgkin's Disease   Intestinal Cancer   Leukemia, Adult Acute   Leukemia, Adult Chronic   Lymphoma   Multiple Myeloma  

ChemIDplus related topics:   Cilengitide  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase I Trial of EMD 121974 in Patients With Advanced or Metastatic Cancer

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

Study Start Date:   December 1999

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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)

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004258

Locations
United States, Indiana
Indiana University Cancer Center    
      Indianapolis, Indiana, United States, 46202-5265

Sponsors and Collaborators
Indiana University Melvin and Bren Simon Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Michael S. Gordon, MD     Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea    
United States, Indiana
Indiana University Cancer Center    
      Indianapolis, Indiana, United States, 46202-5265
Indiana University Melvin and Bren Simon Cancer Center
National Cancer Institute (NCI)
Study Chair:     Michael S. Gordon, MD     Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea    
  More Information

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

Study ID Numbers:   CDR0000067505, IUMC-9909-40, NCI-T99-0076
First Received:   January 28, 2000
Last Updated:   May 23, 2008
ClinicalTrials.gov Identifier:   NCT00004258
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
untreated hairy cell leukemia  
progressive hairy cell leukemia, initial treatment  
refractory hairy cell leukemia  
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 plasma cell neoplasm
Waldenstrom macroglobulinemia
stage III multiple myeloma
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent adult acute myeloid leukemia

Study placed in the following topic categories:
Polycythemia
Blast Crisis
Chronic myelogenous leukemia
Chronic myelomonocytic leukemia
Hodgkin lymphoma, adult
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Lymphoma, large-cell, immunoblastic
Duodenal Neoplasms
Preleukemia
Hemorrhagic Disorders
Leukemia, Prolymphocytic
Multiple myeloma
Hemorrhagic thrombocythemia
Neoplasm Metastasis
Thrombocythemia, Hemorrhagic
Acute myeloid leukemia, adult
Hodgkin Disease
Essential thrombocytosis
Chronic lymphocytic leukemia

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Neoplasms by Site
Disease
Pathologic Processes
Neoplasms by Histologic Type
Immune System Diseases
Jejunal Diseases
Blood Protein Disorders
Syndrome
Cardiovascular Diseases
Ileal Diseases

Source: National Library of Medicine (NLM) July 10, 2008