Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Study Of Continuous Infusion EMD 121974 In Patients With Solid Tumors
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 blood flow to the cancer
| Status | Completed |
| Enrollment | 45 |
| Est. completion date | |
| Est. primary completion date | June 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Chicago Comprehensive Cancer Center | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum feasible dose defined as the highest dose studied for which the incidence of DLT is less than 33% or the highest safe dose in our study, limited to a maximum MFD dose of 40 mg/hr | 4 weeks | Yes | |
| Secondary | Pharmacokinetics of EMD 121974 | Up to 8 weeks | No |
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