Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

NCT00052715 | Terminated Phase 2 Results DMC

• 3 other identifiers: NABTC-0105CDR0000258685NCI-2012-02506
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Biological therapies such as poly-ICLC use different ways to stimulate the immune system and stop tumor cells from growing. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining biological therapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining poly-ICLC with radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival in Pts With Newly Diagnosed GBM

  Overall survival from surgical diagnosis in patients with Newly Diagnosed GBM

  2 years

Secondary Outcomes (5)

• To Determine 6 Months Progression Free Survival

  6 months

• Determine the 12-month Survival Rate

  1 year

• to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients

  2 years

• To Determine the Change in Neurological Status in Patients With Glioblastoma Treated With External Beam Radiotherapy and Poly-ICLC

  1 year

• To Determine Tumor Response

  2 years

Study Arms (1)

poly-ICLC Newly diagnosed GBM

EXPERIMENTAL

Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy Intramuscular injection Drug Poly-ICLC

Drug: poly ICLC

Interventions

poly ICLC DRUG

poly-ICLC Newly diagnosed GBM

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed intracranial glioblastoma multiforme (GBM) or gliosarcoma by biopsy or resection within the past 28 days PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * More than 8 weeks Hematopoietic * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic * Bilirubin less than 2 times upper limit of normal (ULN) * SGOT less than 2 times ULN Renal * Creatinine less than 1.5 mg/dL Other * No significant medical illness that cannot be controlled adequately with appropriate therapy or that would compromise tolerability of study therapy * No other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off all therapy for that disease for at least 3 years * No active infection * No disease that would obscure toxicity or dangerously alter drug metabolism * No other serious concurrent medical illness * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior polifeprosan 20 with carmustine implant (Gliadel wafer) * No concurrent chemotherapy Endocrine therapy * Concurrent corticosteroids to treat symptoms or prevent complications are allowed Radiotherapy * No prior radiotherapy to the brain * No concurrent stereotactic radiosurgery * No concurrent brachytherapy Surgery * See Disease Characteristics Other * No prior cytotoxic or noncytotoxic drug therapy for GBM * No prior experimental drug therapy for GBM * No other concurrent cytotoxic or noncytotoxic drug therapy for GBM * Concurrent analgesics, antiepileptics, or other drugs to treat symptoms or prevent complications are allowed

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 (1)

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Related Publications (1)

• Butowski N, Chang SM, Junck L, DeAngelis LM, Abrey L, Fink K, Cloughesy T, Lamborn KR, Salazar AM, Prados MD. A phase II clinical trial of poly-ICLC with radiation for adult patients with newly diagnosed supratentorial glioblastoma: a North American Brain Tumor Consortium (NABTC01-05). J Neurooncol. 2009 Jan;91(2):175-82. doi: 10.1007/s11060-008-9693-3. Epub 2008 Sep 17.

  PMID: 18797818 RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioblastoma; Gliosarcoma

Interventions

poly ICLC

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Enrollment was prematurely discontinued after the results of the EORTC phase-3 study defined the standard of care for newly diagnosed glioblastoma patients as radiotherapy plus concomitant and adjuvant temozolomide (2005)

Results Point of Contact

• Title: Michael Prados, MD
• Organization: North American Brain Tumor Consortium

jfisher@jhmi.edu

410-955-8837

Study Officials

• Michael Prados, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

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: January 24, 2003
• First Posted: January 27, 2003
• Study Start: October 23, 2002
• Primary Completion: February 25, 2006
• Study Completion: January 1, 2009
• Last Updated: July 18, 2018
• Results First Posted: March 16, 2017

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)