Clinical trial · Interventional
Chemotherapy, Radiation Therapy, and Vaccine Therapy With Basiliximab in Treating Patients With Glioblastoma Multiforme That Has Been Removed by Surgery
Zenapax®-Activated Peptide ImmunoTherapy [ZAP IT]
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Vaccines may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as basiliximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving chemotherapy, radiation therapy, and vaccine therapy together with basiliximab is a more effective treatment for glioblastoma multiforme than chemotherapy, radiation therapy, and vaccine therapy alone. PURPOSE: This randomized phase I trial is studying the side effects and best way to give chemotherapy and radiation therapy followed by vaccine therapy with basiliximab in treating patients with glioblastoma multiforme that has been removed by surgery.
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 |
|---|---|---|---|
| Malignant Neoplasms of Brain | Malignant Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| daclizumab | Biological | — | UNRESOLVED |
| PEP-3-KLH | Biological | — | UNRESOLVED |
| PEP-3-KLH conjugate vaccine | Biological | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Temozolomide, PEP-3-KLH conjugate vaccine, and daclizumab
- interventionNames
- Biological: PEP-3-KLH conjugate vaccine
- Biological: daclizumab
- Drug: temozolomide
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Temozolomide, PEP-3-KLH conjugate vaccine, and normal saline
- interventionNames
- Biological: PEP-3-KLH conjugate vaccine
- Drug: temozolomide
- Other: placebo
- type
- EXPERIMENTAL
- label
- Basiliximab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histopathologic diagnosis of WHO grade III or WHO grade IV high grade glioma * Newly diagnosed disease * Meets the following criteria: * The patient must undergo leukapheresis for immunologic monitoring * Tumor expression of EGFRvIII by immunohistochemistry (IHC) or polymerase chain reaction (PCR) * No radiographic or cytologic evidence of leptomeningeal or multicentric disease PATIENT CHARACTERISTICS: * Karnofsky performance status ≥ 80% * Curran Group status of I-IV * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No conditions that will potentially confound the study results, including any of the following: * Active infection requiring treatment or an unexplained febrile (\> 101.5°F) illness * Known immunosuppressive disease or known HIV infection * Unstable or severe intercurrent medical conditions such as severe heart or lung disease * No demonstrated allergy to TMZ * Able to tolerate TMZ * TMZ-induced lymphopenia allowed * No prior allergic reaction to daclizumab/basiliximab or its components PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No other conventional therapeutic intervention other than steroids, radiation, or temozolomide (TMZ) prior to enrollment * No prior allogeneic solid organ transplantation * No prior inguinal lymph node dissection, radiosurgery, brachytherapy, or radiolabeled monoclonal antibodies * No corticosteroids at a dose above physiologic level except nasal or inhaled steroid at the time of first study vaccination * For the purposes of this study, physiologic dose is defined as \< 2 mg of dexamethasone/day * Once study vaccinations have been initiated, if patients subsequently require increased steroids, they are permitted to remain on the study * No prior daclizumab/basiliximab
References
Publications (1)
- RESULTSampson JH, Schmittling RJ, Archer GE, Congdon KL, Nair SK, Reap EA, Desjardins A, Friedman AH, Friedman HS, Herndon JE 2nd, Coan A, McLendon RE, Reardon DA, Vredenburgh JJ, Bigner DD, Mitchell DA. A pilot study of IL-2Ralpha blockade during lymphopenia depletes regulatory T-cells and correlates with enhanced immunity in patients with glioblastoma. PLoS One. 2012;7(2):e31046. doi: 10.1371/journal.pone.0031046. Epub 2012 Feb 27. PMID 22383993