Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma

NCT00498927 | Completed Phase 2 Results

• 4 other identifiers: 07-064P30CA008748MSKCC-07064SPRI-PO5096
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: 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. PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with recurrent glioblastoma multiforme or other malignant glioma.

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumor; adult giant cell glioblastoma; adult glioblastoma; adult gliosarcoma; adult anaplastic astrocytoma; adult diffuse astrocytoma; adult pilocytic astrocytoma; adult subependymal giant cell astrocytoma; adult anaplastic ependymoma; adult ependymoma; adult myxopapillary ependymoma; adult subependymoma; adult anaplastic oligodendroglioma; adult oligodendroglioma; adult brain stem glioma; adult mixed glioma; adult pineal gland astrocytoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS) Rate at 6 Months

  Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  at 6 months

Secondary Outcomes (1)

• Overall Survival

  2 years

Study Arms (1)

Temozolomide

EXPERIMENTAL

Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.

Drug: temozolomide; Genetic: protein expression analysis; Genetic: reverse transcriptase-polymerase chain reaction; Other: diagnostic laboratory biomarker analysis; Other: immunoenzyme technique

Interventions

temozolomide DRUG

Temozolomide

protein expression analysis GENETIC

Temozolomide

reverse transcriptase-polymerase chain reaction GENETIC

Temozolomide

diagnostic laboratory biomarker analysis OTHER

Temozolomide

immunoenzyme technique OTHER

Temozolomide

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Pathologically diagnosed glioblastoma multiforme or other malignant glioma * Recurrent disease * Must have received prior temozolomide PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Granulocyte count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * SGOT ≤ 2.5 times upper limit of normal (ULN) * Creatinine ≤ 2 times ULN * Bilirubin ≤ 2 times ULN * No other active malignancy except for cervical carcinoma in situ or basal cell carcinoma of the skin * No serious medical or psychiatric illness that, in the opinion of the investigator, would preclude study treatment * No medical condition that precludes swallowing pills * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from all prior therapy

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Weill Medical College of Cornell University: collaborator
• Schering-Plough: collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• Omuro A, Chan TA, Abrey LE, Khasraw M, Reiner AS, Kaley TJ, Deangelis LM, Lassman AB, Nolan CP, Gavrilovic IT, Hormigo A, Salvant C, Heguy A, Kaufman A, Huse JT, Panageas KS, Hottinger AF, Mellinghoff I. Phase II trial of continuous low-dose temozolomide for patients with recurrent malignant glioma. Neuro Oncol. 2013 Feb;15(2):242-50. doi: 10.1093/neuonc/nos295. Epub 2012 Dec 14.

  PMID: 23243055 DERIVED

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms; Glioblastoma; Gliosarcoma; Astrocytoma; Ependymoma; Glioma, Subependymal; Oligodendroglioma; Glioma

Interventions

Temozolomide; Reverse Transcriptase Polymerase Chain Reaction; Immunoenzyme Techniques

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; Immunoassay; Immunologic Techniques; Immunohistochemistry; Molecular Probe Techniques

Results Point of Contact

• Title: Dr. Antonio Omuro
• Organization: Memorial Sloan Kettering Cancer Center

omuroa@mskcc.org

212 639 7523

Study Officials

• Antonio Omuro, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Thomas Kaley, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: July 10, 2007
• First Posted: July 11, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 29, 2016
• Results First Posted: February 29, 2016

Record last verified: 2016-02

Locations

US (1)