Status:
COMPLETED
Cilengitide (EMD 121974) in Treating Patients With Advanced Solid Tumors or Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
AIDS-related Peripheral/Systemic Lymphoma
AIDS-related Primary CNS Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of EMD 121974 in treating patients with solid tumors or lymphoma. Cilengitide (EMD 121974) may stop the growth of cancer cells by stopping...
Detailed Description
PRIMARY OBJECTIVES: I. 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. II. ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- Performance status - Karnofsky 70-100%
- 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
- Bilirubin normal (unless due to Gilbert's syndrome)
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No prior proven gastric or duodenal ulcer
- No clinically significant gastrointestinal blood loss within the past 6 weeks
- 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
- No prior cilengitide (EMD 121974)
- No other concurrent biologic therapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- No concurrent chemotherapy
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy and recovered
- No concurrent palliative radiotherapy
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00077155
Start Date
December 1 2003
Last Update
January 24 2013
Active Locations (1)
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1
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470