HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed GBM
Condition: Brain and Central Nervous System Tumors
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms
Intervention: HSPPC-96; Temozolomide; Standard Surgical Resection
Intervention description: Autologous tumor-derived heat shock protein peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly for 4 consecutive weeks and monthly following standard treatment with radiation and temozolomide.; Maintenance temozolomide treatment is given 2 weeks after administration of the fourth vaccine at an initial dose of 150 mg per square meter (mg/m2) for 5 consecutive days in a 28-day cycle. The dose was increased to 200 mg/m2 for 5 days in subsequent cycles.; Patients will undergo standard surgical resection of intracranial tumor
Intervention MeSH terms: Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Newly Diagnosed Glioblastoma Multiforme, vaccine

Summary:

      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.
    

Eligibility criteria:

        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