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

Glioblastoma Multiforme Clinical Trial

Official title:

A Phase II Trial of Radiation Plus Temozolomide Followed by Adjuvant Temozolomide and Poly-ICLC in Patients With Newly Diagnosed Glioblastoma Multiforme

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00262730
• Other study ID #: NABTT-0501
• Secondary ID: U01CA062475NABTT
• Status: Completed
• Phase: Phase 2
• Start date: January 2006
• Est. completion date: April 2010

Study information

• Verified date: May 2019
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

Primary

• Evaluate the safety and efficacy of radiation plus low-dose temozolomide followed by adjuvant temozolomide and intramuscular poly ICLC for adult patients with newly diagnosed glioblastoma multiforme.

Secondary

• Estimate the frequency of toxicity associated with this treatment regimen.

OUTLINE: This is an open-label, multicenter study.

• Induction chemoradiotherapy: Patients undergo radiotherapy once daily, 5 days a week, for 6 weeks. During the same 6 weeks, patients also receive oral temozolomide once daily. Four weeks later, patients are evaluated for disease progression. Patients with progressive disease are removed from the study. Patients with no progressive disease proceed to maintenance therapy.

• Maintenance therapy: Patients receive oral temozolomide once daily on days 1-5 (week 1). Patients also receive poly ICLC intramuscularly three times a week in weeks 2-8. Courses repeat every 9 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 2 months for survival.

PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: April 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Drug:
• poly ICLC
20 mcg/kg 3x each week (Maintenance cycles)
• temozolomide
daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)

Radiation:
• radiation therapy
RT: 60 Gy (6 weeks) concomitant therapy

Locations

Country	Name	City	State
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida	Tampa	Florida
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Rosenfeld MR, Chamberlain MC, Grossman SA, Peereboom DM, Lesser GJ, Batchelor TT, Desideri S, Salazar AM, Ye X. A multi-institution phase II study of poly-ICLC and radiotherapy with concurrent and adjuvant temozolomide in adults with newly diagnosed gliob — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	survival time is defined from time of histological diagnosis to death occurrence.	30 months