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Cilengitide (EMD 121974) in Treating Patients With Advanced Solid Tumors or Lymphoma
This study has been completed.

First Received on February 10, 2004.   Last Updated on June 19, 2010   History of Changes
Sponsor: University of Chicago
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00077155
  Purpose

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.


Condition Intervention Phase
Lymphoma
Unspecified Adult Solid Tumor, Protocol Specific
Drug: cilengitide
Phase I

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study Of Continuous Infusion EMD 121974 In Patients With Solid Tumors

Resource links provided by NLM:


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

Estimated Enrollment: 45
Study Start Date: January 2004
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00077155

Locations
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Samir D. Undevia, MD University of Chicago
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00077155     History of Changes
Other Study ID Numbers: CDR0000349535, UCCRC-12774A, NCI-6362
Study First Received: February 10, 2004
Last Updated: June 19, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
stage III adult Burkitt lymphoma
stage IV adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage IV adult lymphoblastic lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
stage III grade 1 follicular lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Immunoblastic
Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 12, 2012