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Cilengitide (EMD 121974) in Treating Patients With Advanced Solid Tumors or Lymphoma
This study is ongoing, but not recruiting participants.
Study NCT00077155   Information provided by National Cancer Institute (NCI)
First Received: February 10, 2004   Last Updated: July 23, 2008   History of Changes

February 10, 2004
July 23, 2008
January 2004
April 2005   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00077155 on ClinicalTrials.gov Archive Site
 
 
 
Cilengitide (EMD 121974) in Treating Patients With Advanced Solid Tumors or Lymphoma
A Phase I Study Of Continuous Infusion EMD 121974 In Patients With Solid Tumors

RATIONALE: Cilengitide (EMD 121974) may stop the growth of cancer cells by stopping blood flow to the cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of EMD 121974 in treating patients with solid tumors or lymphoma.

OBJECTIVES:

Primary

  • Determine the dose-limiting toxicity, maximum feasible dose, and recommended phase II dose of cilengitide (EMD 121974) in patients with advanced solid tumors or lymphoma.
  • Determine the safety and tolerability of this drug in these patients.

Secondary

  • Determine the pharmacokinetics of this drug in these patients.
  • Determine the antineoplastic activity of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive cilengitide (EMD 121974) IV continuously on weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

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 toxicity.

PROJECTED ACCRUAL: Approximately 45 patients will be accrued for this study within 5.3-13 months.

Phase I
Interventional
Treatment
  • Lymphoma
  • Unspecified Adult Solid Tumor, Protocol Specific
Drug: cilengitide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
45
 
April 2005   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid tumor or lymphoma
  • Refractory to standard therapy or no standard therapy exists
  • Measurable or evaluable disease
  • No active brain metastases

    • Previously treated brain metastases allowed provided the patient is not currently receiving corticosteroids
    • Primary brain neoplasms allowed, regardless of corticosteroid use

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No life-threatening bleeding diathesis within the past 6 months

Hepatic

  • Bilirubin normal (unless due to Gilbert's syndrome)

Renal

  • Not specified

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Gastrointestinal

  • No prior proven gastric or duodenal ulcer
  • No clinically significant gastrointestinal blood loss within the past 6 weeks

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior CNS hemorrhage
  • No psychiatric illness or social situation that would preclude study compliance
  • No other concurrent uncontrolled illness
  • No ongoing or active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior cilengitide (EMD 121974)
  • No other concurrent biologic therapy

Chemotherapy

  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics

Radiotherapy

  • More than 4 weeks since prior radiotherapy and recovered
  • No concurrent palliative radiotherapy

Surgery

  • Not specified

Other

  • No other concurrent anticancer agents or therapies intended to treat the malignancy
  • No other concurrent investigational agents
  • No concurrent anticoagulation therapy that increases INR or aPTT above the normal range

    • Line prophylaxis allowed
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00077155
 
CDR0000349535, UCCRC-12774A, NCI-6362
University of Chicago
National Cancer Institute (NCI)
Study Chair: Samir D. Undevia, MD University of Chicago
National Cancer Institute (NCI)
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP