Clinical trial · Interventional
EMD 121974 in Treating Patients With Progressive or Recurrent Glioma
A Phase I/II Trial of EMD 121974 for Treatment of Patients With Recurrent Anaplastic Gliomas
NCT00006093CI-TRIAL-00010993completedPhase 1 / Phase 2ClinicalTrials.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)
RATIONALE: EMD 121974 may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I/II trial to study the effectiveness of EMD 121974 in treating patients who have progressive or recurrent malignant glioma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cilengitide | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed malignant glioma that is progressive or recurrent after radiotherapy and/or chemotherapy
* Eligible subtypes:
* Anaplastic astrocytoma
* Anaplastic oligodendroglioma
* Glioblastoma multiforme
* Prior low-grade glioma that has progressed to a high-grade glioma (by biopsy) after radiotherapy and/or chemotherapy allowed
* Measurable disease by volumetric and magnetic resonance perfusion scan
* Prior biopsy or resection of recurrent brain tumor allowed
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin normal
* Transaminases no greater than 2.5 times upper limit of normal
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No advanced coronary artery disease
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No serious concurrent infection or medical illness that would preclude study
* No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer
* No history of wound healing disorders
* No peptic ulcer disease within the past year
* Mini mental score of at least 15
* Willing and able to undergo MRI
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent filgrastim (G-CSF)
Chemotherapy:
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
* No more than 2 prior chemotherapy regimens
Endocrine therapy:
* Prior corticosteroids allowed if on stable dose for at least 5 days prior to study
* Concurrent corticosteroids (e.g., dexamethasone) allowed as clinically needed
Radiotherapy:
* See Disease Characteristics
* At least 3 months since prior radiotherapy and recovered
Surgery:
* See Disease Characteristics
* At least 1 week since prior surgery and recovered
* No concurrent elective surgery or dental extractions
Other:
* No other concurrent investigational agentsReferences
Publications (2)
- RESULTNabors LB, Mikkelsen T, Rosenfeld SS, Hochberg F, Akella NS, Fisher JD, Cloud GA, Zhang Y, Carson K, Wittemer SM, Colevas AD, Grossman SA. Phase I and correlative biology study of cilengitide in patients with recurrent malignant glioma. J Clin Oncol. 2007 May 1;25(13):1651-7. doi: 10.1200/JCO.2006.06.6514. PMID 17470857
- RESULTNabors LB, Rosenfeld SS, Mikkelsen T, et al.: NABTT 9911: a phase I trial of EMD 121974 for treatment of patients with recurrent malignant gliomas. [Abstract] Neuro-Oncology 6 (4): TA-39, 379, 2004.