Clinical trial · Interventional
A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma
Phase I/II Intraventricular DepoCyt (OD # 06-2348) in Glioblastoma (76,730, 11/06)
NCT01044966CI-TRIAL-00037051terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated due to lack of adequate patient enrollment into trial.
Summary
Brief summary (as posted)
Current treatments for Glioblastoma Multiforme (GBM), the most common and malignant primary brain tumor are inadequate and as such, the median survival for most patients with GBM is on the order of months, even after cytoreductive surgery, radiation and chemotherapy. This study aims to develop a new treatment for GBM by suppressing glial progenitor cells that surround the ventricular system in patients with these aggressive tumors because it is these regions that appear to act as an incubator for future recurrences resulting in patient death. Considering the lack of significant treatment options for patients with this uniformly fatal disease, this is an important translational clinical study to perform.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytoma | Astrocytoma | CURATED_BROADER | 0.80 |
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ITV DepoCyt + Temozolomide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ITV DepoCyt + Temozolomide
- description
- Patients will undergo an induction phase of intraventricular (ITV) DepoCyt, using the dosage determined from the Phase I portionPatients with stable disease (clinically and radiographically), not exhibiting systemic toxicity, will undergo a three month consolidation phase of ITV DepoCyt, for one month (Cycles 3-6). Patients without progression or toxicity will undergo maintenance therapy using ITV DepoCyt every four weeks (+/- 3 days) for a maximum of 8 months (cycles 7-14) or until recurrence or toxicity ensues. Oral metronomic Temozolomide dosing of 75 mg/m2 daily for 21 days followed by 7 days off will be given throughout the Induction, Consolidation, and Maintenance Phases of the ITV DepoCyt described above.
- interventionNames
- Drug: ITV DepoCyt + Temozolomide
Primary outcomes (1)
- measure
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
- timeFrame
- 52 weeks
- description
- The type and number of adverse events will be recorded and reported by the number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria:
* Age Patients must be at least 18 years of age but no older than 85 years.
* Diagnosis Patients with the histological diagnosis of recurrent GBM made either by biopsy or resection of recurrent disease. Cytological evidence of malignant cells in CSF and/or clinical and radiographic evidence of leptomeningeal disease are irrelevant in terms of inclusion or exclusion into this study. Bihemispheric extension ("butterfly GBM"), multi-focality, and/or subependymal spread are not contraindications to enrollment.
* Prior therapy Patients must have had an initial diagnosis of "malignant glioma" (WHO grade III or IV) and failed initial surgical resection followed by standard adjuvant therapy including external beam radiotherapy to a 2cm margin of 60 Gy, and standard temozolomide chemotherapy of 150 to 200 mg per square meter for 5 days during each 28-day cycle prior to "recurrence." Patients must not have received more than one other systemic or ITV adjuvant chemotherapy regimen in addition to temozolomide prior to enrollment, not including intracavitary Gliadel wafer placement. Prior Gliadel wafer placement is not a contradiction to patient enrollment in this trial.
* Performance Status Patients must have Karnofsky performance status (KPS) of ≥ 60%.
* Recovery from Prior Therapy Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy, prior to entering this study and must be without significant systemic illness (e.g. infection unresponsive to treatment after 7 days). Such that they are healthy enough to safely undergo tumor biopsy and Ommaya reservoir placement. Patients must not have received any systemic therapy for recurrent disease within 3 weeks (6 weeks if a nitrosourea), or irradiation within 8 weeks prior to treatment on this study.
* Hematologic Status Patients must have a platelet count \> 75,000/mm3 and ANC \> 1500/mm3 within 72 hours prior to ITV DepoCyt treatment.
* Hepatic and Renal Status Patients must have adequate liver function (total bilirubin \< 2.0 mg%; ALT, and AST \< 4 times normal); adequate renal function (serum creatinine \<1.6 mg, and BUN \< 22); normal serum electrolytes (sodium, potassium, calcium, magnesium, and phosphorus).
* Informed Consent (See Appendix) All patients or their legal guardians must sign a document of informed consent indicating their awareness of the investigational nature and the risks of this study.
Exclusion Criteria:
* Patients younger than 18 or older than 85 years of age.
* Patients with histological diagnoses other than recurrent GBM.
* Patients with a Karnofsky performance status (KPS) \< 60%.
* Patients that have received more than one other systemic or ITV adjuvant chemotherapy regimen in addition to temozolomide, not including intracavitary Gliadel wafer placement.
* Patients concurrently receiving other therapies (either brachytherapy or systemic) designed specifically to treat the recurrent GBM.
* Patients within 8 weeks of receiving stereotactic or external beam irradiation.
* Patients with a platelet count \< 75,000/mm3 and ANC \< 1500/mm3 within 72 hours prior to ITV DepoCyt and/or oral temozolomide treatment.
* Patients with liver dysfunction (total bilirubin \> 2.0 mg%; ALT, and AST \> 4 times normal).
* Patients with renal dysfunction (serum creatinine \>1.6 mg, and BUN \> 22).
* Patients with abnormal serum electrolytes (sodium, potassium, calcium, magnesium, and phosphorus).
* Patients with contraindications to having placement of a ventricular access device such as Ommaya reservoir.
* Patients with clinical and/or neuroradiographic evidence of hydrocephalus or increased intracranial pressure.
* Patients with signs and symptoms of systemic infection precluding them from receiving chemotherapy or prohibiting Ommaya reservoir placement.
* Pregnant and breast feeding women will be excluded. All other women of childbearing years must have a negative serum pregnancy test.
* Patients with a ventricular-peritoneal or ventricular-atrial shunt.
* Prisoners will be excluded from this study.
* Patients or their legal guardians not willing or able to sign the informed consent document.References
Publications (0)
Data not yet available
No reference posted for this study.