Chemotherapy, Radiation Therapy, and Vaccine Therapy With Basiliximab in Treating Patients With Glioblastoma Multiforme That Has Been Removed by Surgery

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: John Sampson
• Collaborator: National Cancer Institute (NCI)
• Treatments: Basiliximab; Daclizumab; Temozolomide; Vaccines

Criteria

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