Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Cilengitide (EMD 121974) in Treating Patients With Advanced Solid Tumors or Lymphoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over NCI UCCRC-12774A NCI-6362, 6362, NCT00077155

Objectives

Primary

1. 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.
2. Determine the safety and tolerability of this drug in these patients.

Secondary

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

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,000/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

University of Chicago Cancer Research Center

Samir Undevia, MD, Protocol chair		Ph: 773-834-8141; 888-824-0200 Email: sundevia@medicine.bsd.uchicago.edu

Registry Information
Official Title		A Phase I Study Of Continuous Infusion EMD 121974 In Patients with Solid Tumors
Trial Start Date		2004-01-30
Trial Completion Date		2005-04-24 (estimated)
Registered in ClinicalTrials.gov		NCT00077155
Date Submitted to PDQ		2003-12-12
Information Last Verified		2007-06-03
NCI Grant/Contract Number		CA69852, CA14599

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