Clinical trial · Interventional
Cilengitide (EMD 121974) in Treating Patients With Advanced Solid Tumors or Lymphoma
A Phase I Study Of Continuous Infusion EMD 121974 In Patients With Solid Tumors
NCT00077155CI-TRIAL-00009078completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (55)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AIDS-related Peripheral/Systemic Lymphoma | — | UNRESOLVED | — |
| AIDS-related Primary CNS Lymphoma | AIDS-Related Primary Central Nervous System Lymphoma | ALIAS | 0.90 |
| Anaplastic Large Cell Lymphoma | Anaplastic Large Cell Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Angioimmunoblastic T-cell Lymphoma | Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type | ALIAS | 0.90 |
| Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ALIAS | 0.90 |
| Intraocular Lymphoma | Primary Intraocular Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Nodal Marginal Zone B-cell Lymphoma | Nodal Marginal Zone Lymphoma | ALIAS | 0.90 |
| Recurrent Adult Burkitt Lymphoma |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cilengitide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (cilengitide)
- description
- 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.
- interventionNames
- Drug: cilengitide
Primary outcomes (1)
- measure
- 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
- timeFrame
- 4 weeks
Secondary outcomes (1)
- measure
- Pharmacokinetics of EMD 121974
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.