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



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

For Condition: Leukemia,adult solid tumor,Lymphoma
Status: Recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Cilengitide (EMD 121974) may stop the growth of cancer cells by stopping blood flow to the cancer. PURPOSE: Phase I trial to study the effectiveness of EMD 121974 in treating patients who have solid tumors or lymphoma.
Details: 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: A total of 16-26 patients will be accrued for this study within 5.3-13 months.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
WalterStadler,  Study Chair,  University of Chicago Cancer Research Center

University of Chicago Cancer Research Center *Recruiting*
Chicago,  Illinois,  60637-1470
United States
Recruiting Walter  Stadler 773-702-4400


Additional Information:
Study ID Numbers:  CDR0000349535;  UCCRC-12774A,NCI-6362
Study Start Date: 
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077155

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4. Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver Dysfunction

5. Azacitidine Plus Phenylbutyrate in Treating Patients With Advanced or Metastatic Solid Tumors That Have Not Responded to Previous Treatment

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