Overview

Radiation Therapy and Temozolomide Followed by Temozolomide and Poly ICLC in Treating Patients With Newly Diagnosed GBM

Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborator:
National Cancer Institute (NCI)
Treatments:
Carboxymethylcellulose Sodium
Dacarbazine
Poly I-C
Poly ICLC
Temozolomide
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