Phase 2
N=97
Radiation Therapy and Temozolomide Followed by Temozolomide and Poly ICLC in Treating Patients With Newly Diagnosed GBM
Glioblastoma Multiforme
Bottom Line
View on ClinicalTrials.gov: NCT00262730 ↗Enrolled (actual)
97
Serious AEs
20.6%
Results posted
Jul 2014
Primary outcome: Primary: Survival — 17.2 months — p=>.1
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- poly ICLC (Drug); temozolomide (Drug); radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival |
17.2 | >.1 |
Summary
RATIONALE: Radiation therapy uses high-energy x-rays 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 or by stopping them from dividing. Biological therapies, such as poly ICLC, may stimulate the immune system in different ways and stop tumor cells from growing. Giving poly ICLC after radiation therapy and temozolomide may stop any remaining tumor cells from growing.
PURPOSE: This phase II trial is studying how well giving radiation therapy together with temozolomide followed by temozolomide and poly ICLC works in treating patients with newly diagnosed glioblastoma multiforme.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme) by biopsy or resection within the past 3 months
PATIENT CHARACTERISTICS:
- Karnofsky performance status ≥ 60%
- Absolute neutrophil count ≥ 1500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin ≤ 1.5 mg/dL
- Transaminases ≤ 4 times above the upper limits of the institutional normal
- Creatinine ≤ 1.7 mg/dL
- Not pregnant or breast-feeding
- Patients must agree to follow acceptable birth control methods to avoid conception
- Negative pregnancy test
- Patients must have a Mini Mental State Exam score of ≥ 15
- No serious concurrent infection or medical illness which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety
- Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin
- Patients who have been free of disease (any prior malignancy) for ≥ five years are eligible for this study
- Patients requiring ongoing therapy for psychoses with antipsychotic medications at the time of enrollment will be ineligible
PRIOR CONCURRENT THERAPY:
- Patients must not have received prior radiation therapy, chemotherapy, immunotherapy or therapy with biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy), or hormonal therapy for their brain tumor
- Prior glucocorticoid therapy is allowed
- Patients must be willing to forego other cytotoxic and non-cytotoxic drug therapy against the tumor while being treated with poly ICLC plus temozolomide on this protocol
- No other concurrent therapy for their tumor (i.e., chemotherapeutics or investigational agents)
- Patients who have received prior Gliadel wafers are not eligible for this study
- No concurrent prophylactic filgrastim (G-CSF)
- No concurrent electron, particle, implant, or stereotactic radiosurgery boost
Data sourced from ClinicalTrials.gov (NCT00262730). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.