Completed

A Phase I Study Of Continuous Infusion EMD 121974 In Patients With Solid Tumors

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What is being tested

cilengitide

Drug
Who is being recruted

Plasmablastic Lymphoma
+46

+ Lymphadenopathy
+ Bacterial Infections and Mycoses
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: December 2003
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2003Actual date on which the first participant was enrolled.

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. Determine the safety and tolerability of this drug in these patients. SECONDARY OBJECTIVES: I. Determine the pharmacokinetics of this drug in these patients. II. 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.

Official TitleA Phase I Study Of Continuous Infusion EMD 121974 In Patients With Solid Tumors 
NCT00077155
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
45 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Plasmablastic Lymphoma
Lymphadenopathy
Bacterial Infections and Mycoses
Burkitt Lymphoma
Chronic Disease
Disease
DNA Virus Infections
Eye Neoplasms
Hematologic Diseases
Herpesviridae Infections
Hodgkin Disease
Immunoblastic Lymphadenopathy
Immune System Diseases
Immunoproliferative Disorders
Infections
Leukemia
Leukemia, Lymphoid
Lymphatic Diseases
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Mycoses
Mycosis Fungoides
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Pathologic Processes
Recurrence
Sezary Syndrome
Syndrome
Tumor Virus Infections
Virus Diseases
Leukemia, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Lymphoma, B-Cell
Lymphoma, T-Cell
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Large B-Cell, Diffuse
Lymphoma, T-Cell, Cutaneous
Lymphoma, Large-Cell, Anaplastic
Lymphoma, B-Cell, Marginal Zone
Epstein-Barr Virus Infections
Lymphoma, Mantle-Cell
Disease Attributes
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Intraocular Lymphoma
Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
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 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.

Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
University of Chicago Comprehensive Cancer CenterChicago, United StatesSee the location
CompletedOne Study Center
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