Status:
COMPLETED
Vaccination-Dendritic Cells With Peptides for Recurrent Malignant Gliomas
Lead Sponsor:
Frank Lieberman
Collaborating Sponsors:
Oncovir, Inc.
Conditions:
Malignant Glioma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a single-institution Phase I/II study designed to evaluate the safety and induction of an immune response, and preliminary clinical response of vaccinations with Type-1 alpha-DCs (alpha-DC1) l...
Detailed Description
This is a single-institution Phase I/II study designed to evaluate the safety, the induction of an immune response, and the preliminary clinical response of vaccinations with Type-1 αDCs (αDC1) loaded...
Eligibility Criteria
Inclusion
- Patients must have a histologically confirmed
- recurrent glioblastoma (GBM)
- anaplastic astrocytoma (AA)
- anaplastic oligodendroglioma (AO)
- anaplastic mixed oligoastrocytoma (AMO)
- other anaplastic glioma
- Patients must have received prior external beam radiotherapy and/or chemotherapy unless patients refused the options.
- Patients may have had treatment for no more than 2 prior relapses. Relapse is defined as progression following initial therapy (i.e. radiation +/- chemo if that was used as initial therapy).
- Patients must be HLA-A2 positive.
- All patients must sign an informed consent document indicating that they are aware of the investigational nature of this study.
- Patients must sign an authorization for the release of their protected health information.
- Patients must be \> 18 years old, and with a life expectancy \> 8 weeks. -Patients must have a Karnofsky performance status of \> 60.
- Patients must have recovered from the toxic effects of prior therapy: 4 weeks from any investigational agent, 4 weeks from prior cytotoxic therapy and/or at least two weeks from vincristine, 4 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count). Any questions related to the definition of non-cytotoxic agents should be directed to the principal investigator.
- Patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism.
- Patients must not have any serious concurrent medical illness.
- Documented negative serum beta-HCG for female patients of child-bearing age.
- Patients must be free of systemic infection. Subjects with active infections (whether or not they require antibiotic therapy) may be eligible after complete resolution of the infection. Subjects on antibiotic therapy must be off antibiotics for at least 7 days before beginning treatment.
- Patients must have adequate organ function as measured by:
- Hematopoietic:
- granulocytes at least 2500/mm3
- lymphocytes at least 1000/mm3
- platelets at least 100,000/mm3
- hemoglobin at least 10.0 g/dL
- Cardiac: Asymptomatic or, if symptomatic, then left ventricular ejection fraction at rest must be at least 50% or within the normal range of the institution. A cardiology clearance will be required for LV ejection fraction 50%.
- Hepatic: AST, ALT, GGT, LDH, Alk phos within 2.5 x upper normal limit and total bilirubin no greater than 2.0 mg/dL.
- Renal: Serum creatinine up to 1.5 x upper normal limit.
- Pretreatment baseline evaluations for laboratory parameters must be obtained within 10 to 18 days of subject registration.
Exclusion
- Pregnant or breast-feeding.
- Presence of metastatic disease.
- Active bacterial, viral or fungal infections. Subjects with active infections (whether or not they require antibiotic therapy) may be eligible after complete resolution of the infection. Subjects on antibiotic therapy must be off antibiotics for at least 7 days before beginning treatment.
- Chemotherapy, biologic therapy or radiation therapy less than one month prior to study entry.
- History or presence of autoimmune disease.
- Use of immunosuppressives within 4 weeks prior to study entry or anticipated use of immunosuppressive agents. Minimum doses of corticosteroid (dexamethasone up to 4 mg/day) is permitted.
- Subjects with uncontrolled pain. -Subjects who have sensitivity to drugs to provide local anesthesia.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00766753
Start Date
December 1 2006
End Date
June 1 2016
Last Update
February 7 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232