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| Tracking Information | |||||
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| First Received Date ICMJE | February 10, 2004 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | January 2004 | ||||
| Estimated Primary Completion Date | April 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00077155 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cilengitide (EMD 121974) in Treating Patients With Advanced Solid Tumors or Lymphoma | ||||
| Official Title ICMJE | A Phase I Study Of Continuous Infusion EMD 121974 In Patients With Solid Tumors | ||||
| Brief Summary | 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. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
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. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: cilengitide | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 45 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | April 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00077155 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000349535, UCCRC-12774A, NCI-6362 | ||||
| Study Sponsor ICMJE | University of Chicago | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | June 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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