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

NCT00262730 | Completed Phase 2 Results DMC

• 4 other identifiers: NABTT-0501U01CA062475NABTT-0501 CDR0000454915NA_00001963
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Glioblastoma Multiforme

Keywords

adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma

Outcome Measures

Primary Outcomes (1)

• Survival

  survival time is defined from time of histological diagnosis to death occurrence.

  30 months

Study Arms (1)

Treatment Arm

EXPERIMENTAL

RT + TMZ 6wks, followed by poly ICLC, temozolomide, radiation: radiation therapy

Drug: poly ICLC; Drug: temozolomide; Radiation: radiation therapy

Interventions

poly ICLC DRUG

20 mcg/kg 3x each week (Maintenance cycles)

Also known as: Holtonol

Treatment Arm

temozolomide DRUG

daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)

Also known as: Temodar

Treatment Arm

radiation therapy RADIATION

RT: 60 Gy (6 weeks) concomitant therapy

Also known as: RT

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (9)

Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham

Birmingham, Alabama, 35294, United States

Location

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, 33612-9497, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Related 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 glioblastoma. Neuro Oncol. 2010 Oct;12(10):1071-7. doi: 10.1093/neuonc/noq071. Epub 2010 Jul 8.

  PMID: 20615924 RESULT

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma

Interventions

poly ICLC; Temozolomide; Radiotherapy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Limitations and Caveats

"Other Adverse Events" not reported for this study. Only serious(grade 3/4)related to either TMZ and/or Poly were reported. Subjects may have experienced grade 1 and grade 2 other adverse event but they have no bearing on clinical outcome of agent

Results Point of Contact

• Title: Director of Adult Brain Tumor Consortium
• Organization: Adult Brain Tumor Consortium Central Office- Johns Hopkins

jfisher@jhmi.edu

410-955-3657

Study Officials

• Myrna Rosenfeld, MD, PhD

  Abramson Cancer Center at Penn Medicine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2005
• First Posted: December 7, 2005
• Study Start: January 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: April 1, 2010
• Last Updated: June 12, 2019
• Results First Posted: July 16, 2014

Record last verified: 2019-05

Locations

US (9)