Clinical trial · Interventional

A Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)

A Phase I-II Study of Allogeneic CMV Specific Cytotoxic T Lymphocytes (CTL) for Patients With Refractory Glioblastoma Multiforme (GBM)

NCT00990496CI-TRIAL-00032755terminatedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Accrual goals not met

Summary

Brief summary (as posted)

The primary purpose of this study is to determine the safety and efficacy of the infusion of partially matched, allogeneic, CMV specific cytotoxic T cells (CTL) for patients with GBM that have failed primary therapy.

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
Glioblastoma Multiforme	Glioblastoma	CURATED_BROADER	0.80

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
CMV Specific Cytotoxic T Lymphocytes (CTL)	Biological	—	UNRESOLVED
Cyclophosphamide	Drug	Cyclophosphamide	ALIAS
Fludarabine	Drug	Fludarabine	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
GBM Treatment
interventionNames
1. Drug: Fludarabine
2. Drug: Cyclophosphamide
3. Biological: CMV Specific Cytotoxic T Lymphocytes (CTL)

Primary outcomes (1)

measure
To determine the incidence of tumor responses, as defined as stable disease, partial, or complete responses after the infusion of CMV CTL.
timeFrame
2 years

Secondary outcomes (3)

measure
To determine the duration and magnitude of donor chimerism post infusion by micro chimerism assays.
timeFrame
2 years
measure
To determine the incidence of increases in CMV pp65 or IE-1 T cells post infusion of allogeneic CMV CTL of GBM patients.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 5 Years
Maximum age: 65 Years

Show eligibility criteria text

Inclusion Criteria:

FOR SCREENING

* Patients must have a histopathologic diagnosis of GBM.
* Patients from 5 to 65 years of age with GBM.

FOR TREATMENT

* GBM has progressed following primary therapy.
* Tumor is CMV pp65 or IE1 positive by immunohistochemistry (IHC).
* Subjects must have pulse oximetry \> or = 94 % on no supplemental oxygen.
* Creatinine clearance must be \> 50 cc/min as estimated by patient's serum creatinine, weight, and age.
* Bilirubin must be \< 2.0 mg/dl and SGOT/SGPT \< 2.5 X normal.
* ECOG performance status must be \< or = 2, and for patients \<16 years of age, Lansky performance status must be \> or = 70%.

Exclusion Criteria:

* Pregnant females
* Subjects who are moribund or who because of cardiac, pulmonary, renal, hepatic or neurologic dysfunction are not expected to survive one month following the T cell infusion

References

Publications (0)

Data not yet available

No reference posted for this study.