Brain and Central Nervous System Tumors Clinical Trial
— HeatShockOfficial title:
PHASE 2, Multi-center, Single Arm Investigation of HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
Verified date | March 2021 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase II trial studies the side effects and how well HSPPC-96 (vitespen) and temozolomide work in treating patients with newly diagnosed glioblastoma multiforme. Vaccines made from a person's tumor cells and heat shock protein peptide may help the body to build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving HSPPC-96 (vitespen) together with temozolomide may kill more tumor cells.
Status | Completed |
Enrollment | 70 |
Est. completion date | June 3, 2014 |
Est. primary completion date | June 3, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Pre-surgery tissue acquisition Inclusion criteria 1. Age > or equal to 18 years old 2. Life expectancy of greater than 12 weeks. 3. Able to read and understand the informed consent document; must sign the informed consent 4. Must have suspected diagnosis of Glioblastoma Multiforme with a surgical intent to resect at least 90% of enhancing disease 5. Must be eligible for post-surgical treatment with radiotherapy and temozolomide Post-radiation therapy/pre-vaccine eligibility Inclusion criteria 1. Agree to use contraception or abstain from sexual activity from the time of consent through 1 month after the end of study drug administration 2. Negative serum pregnancy test for female patients of childbearing potential 3. Patients with histologically proven, non-progressive glioblastoma multiforme (GBM) 4. Patient must have received standard of care radiation and temozolomide therapy 5. Must have undergone a at least a 90% resection (determined by the principal investigator (PI)) measured by postoperative magnetic resonance imaging (MRI) scan, T1-weighted contrast scan, or CT scan if clinically indicated, performed within 72 hours after surgery 6. All radiotherapy must be discontinued at least 2 weeks and no more than 5 weeks prior to the first planned vaccine administration 7. Availability of at least 4 doses of vaccine (at least 4 vials for clinical administration produced from the tumor provided) 8. Karnofsky functional status rating > or equal to 70 9. Adequate bone marrow function including the absence of lymphopenia (ANC > 1,500/ mm3; absolute lymphocyte count (ALC) > 500/mm3 ; platelet count >100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase (AST), alanine amino transferase (ALT), and alkaline phosphatase <2.5 times institutional upper limit of normals [IULNs] and bilirubin (total) <1.5 mg*IULN), and adequate renal function (BUN and creatinine <1.5 times IULNs Exclusion Criteria: Pre-surgery tissue acquisition 1. Current diagnosis of Human Immunodeficiency Virus (HIV testing is not required per protocol) 2. Any prior diagnosis of any other cancer or other concurrent malignancy, with the exception of adequately treated nonmetastatic in situ carcinoma of the uterine cervix or nonmetastatic nonmelanoma skin cancer unless in complete remission and off all therapy for that disease for a minimum of 5 years 3. Any systemic autoimmune disease (e.g., Hashimoto's thyroiditis) and/or any history of primary or secondary immunodeficiency 4. Any prior therapy for glioma 5. Planned use or current use of other investigational therapy for the treatment of glioma Post-radiation therapy/pre-vaccine Exclusion 1. Inability to comply with study-related procedures 2. Prior diagnosis of any other cancer or other concurrent malignancy, with the exception of adequately treated nonmetastatic in situ carcinoma of the uterine cervix or nonmetastatic nonmelanoma skin cancer unless in complete remission and off all therapy for that disease for a minimum of 5 years 3. Current or active use of chemotherapy (except temozolomide) or immune therapy 4. Contrast MRI findings (or CT scan if MRI is clinically contraindicated) consistent with progression per protocol defined modified Response assessment in neuro-oncology criteria (RANO) criteria. Progression prior to vaccination as determined by the Principal Investigator 5. Patients with active uncontrolled infection 6. Evidence of bleeding diathesis 7. Unstable or severe intercurrent medical conditions 8. Female patients who are pregnant or breastfeeding |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Hospital | Baltimore | Maryland |
United States | Northwestern University | Chicago | Illinois |
United States | University of Miami | Miami | Florida |
United States | Northern Westchester Hospital | Mount Kisco | New York |
United States | Columbia University | New York | New York |
United States | University of Oklahoma | Oklahoma City | Oklahoma |
United States | The Valley Hospital | Paramus | New Jersey |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Agenus Inc. |
United States,
Bloch O, Lim M, Sughrue ME, Komotar RJ, Abrahams JM, O'Rourke DM, D'Ambrosio A, Bruce JN, Parsa AT. Autologous Heat Shock Protein Peptide Vaccination for Newly Diagnosed Glioblastoma: Impact of Peripheral PD-L1 Expression on Response to Therapy. Clin Canc — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Treatment-Related Adverse Events of Any Grade | Up to 3 years | ||
Primary | Median Overall Survival | Overall survival is defined as the time from surgical resection to death of any cause. | Up to 3 years | |
Secondary | Median Progression Free Survival (PFS) | PFS is defined as the duration of progression-free survival from the time from resection until either documented disease progression or death | Up to 3 years | |
Secondary | Median PD-L1 Positivity in Circulating Myeloid Cells | Circulating myeloid cells (CD45+/CD11b+) obtained from patients at the time of surgery were analyzed for PD-L1 expression to determine the percent of myeloid cells positive for PD-L1 (cut off for positivity determined relative to Fluorescence Minus One (FMO) and isotype control). | Up to 53 Weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT00006080 -
Fenretinide in Treating Patients With Recurrent Malignant Glioma
|
Phase 2 | |
Recruiting |
NCT00887146 -
Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma
|
Phase 3 | |
Suspended |
NCT00935090 -
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
|
N/A | |
Completed |
NCT00621686 -
Bevacizumab and Sorafenib in Treating Patients With Recurrent Glioblastoma Multiforme
|
Phase 2 | |
Completed |
NCT00112502 -
Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme
|
Phase 2 | |
Terminated |
NCT00227032 -
Erlotinib in Treating Patients With Progressive Glioblastoma Multiforme
|
Phase 1 | |
Terminated |
NCT00243022 -
Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme
|
Phase 2 | |
Active, not recruiting |
NCT00087815 -
Hyperbaric Oxygen Therapy in Treating Patients With Radiation Necrosis of the Brain
|
N/A | |
Active, not recruiting |
NCT00278278 -
Combination Chemotherapy and Radiation Therapy With or Without Methotrexate in Treating Young Patients With Newly Diagnosed Gliomas
|
Phase 3 | |
Completed |
NCT00416819 -
Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
|
N/A | |
Completed |
NCT00052286 -
Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
|
N/A | |
Completed |
NCT00006093 -
EMD 121974 in Treating Patients With Progressive or Recurrent Glioma
|
Phase 1/Phase 2 | |
Recruiting |
NCT00004129 -
Phosphorus 32 in Treating Patients With Glioblastoma Multiforme
|
Phase 1 | |
Completed |
NCT00004212 -
DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
Completed |
NCT00003417 -
Computer Planned Radiation Therapy Plus Chemotherapy in Treating Patients With Glioblastoma Multiforme
|
Phase 1/Phase 2 | |
Completed |
NCT00003173 -
High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors
|
Phase 2 | |
Completed |
NCT00003020 -
LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases
|
Phase 1 | |
Completed |
NCT00008008 -
Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Malignant Glioma
|
Phase 2 | |
Completed |
NCT00003464 -
Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme
|
Phase 2 |