Status:
COMPLETED
Cellular Adoptive Immunotherapy Using Genetically Modified T-Lymphocytes in Treating Patients With Recurrent or Refractory High-Grade Malignant Glioma
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
RATIONALE: Cellular adoptive immunotherapy may stimulate the immune system in different ways and stop cancer cells from growing. PURPOSE: This clinical trial is studying the side effects of cellular ...
Detailed Description
OBJECTIVES: Primary * To assess the feasibility and safety of cellular immunotherapy utilizing ex vivo expanded autologous CD8-positive T-cell clones genetically modified to express the IL-13 zetaki...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed malignant glioma at original diagnosis
- Grade III or IV disease
- Refractory or recurrent disease
- Unifocal site of original disease in cerebral cortex
- No clinical evidence of progressive encephalopathy
- Has not undergone recent re-resection of recurrent or progressive disease
- No communication between the tumor resection cavity and the ventricles and deep cerebrospinal fluid pathways as documented by post-operative MRI scan
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Life expectancy \> 3 months
- WBC ≥ 2,000/dL
- ANC \> 1,000/dL
- Platelet count ≥ 100,000/dL (unsupported by transfusion or growth factor)
- Creatinine \< 1.6 mg/dL
- Bilirubin \< 1.5
- SGOT and SGPT \< 2 times upper limit of normal
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to understand protocol basic elements and/or risks/benefits of participating in this pilot study
- No requirement for supplemental oxygen to keep saturation \> 95% that is not expected to resolve within 2 weeks
- No uncontrolled cardiac arrhythmia
- No hypotension requiring pressor support
- No renal dialysis dependency
- No refractory seizure disorder
- No concurrent non-malignant illness that is poorly controlled with treatment or is of such severity the investigators deem it unwise to enter the patient on protocol
- No severe infection for which patient is being treated
- No history of ganciclovir and/or Prohance contrast allergy or intolerance
- No HIV positivity within the past 3 months
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Must have recovered from major surgery
- At least 4 weeks since primary therapy and no steroid dependence
- At least 2 weeks since prior adjuvant cytotoxic chemotherapy and recovered
- No concurrent systemic corticosteroids, except for use in managing T-cell therapy toxicity
- No concurrent immunotherapy (i.e., interferons, vaccines, or other cellular products)
- No concurrent pentoxifylline
- No other concurrent investigative agents
- No concurrent ganciclovir or ganciclovir derivative
- No concurrent acyclovir for non-life threatening herpes virus infection
Exclusion
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00730613
Start Date
February 1 2002
End Date
August 1 2011
Last Update
October 9 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.