search
Back to results

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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
temozolomide
protein expression analysis
reverse transcriptase-polymerase chain reaction
diagnostic laboratory biomarker analysis
immunoenzyme technique
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Temozolomide

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival
All patients will have their tumor measurements recorded at baseline and at the time of each MRI scan. Lesions must be measured in two dimensions. The dose of gadolinium must be held constant from scan to scan. Macdonald criteria will be used for assessment of tumor response.

Full Information

First Posted
July 10, 2007
Last Updated
February 1, 2016
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI), Weill Medical College of Cornell University, Schering-Plough
search

1. Study Identification

Unique Protocol Identification Number
NCT00498927
Brief Title
Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma
Official Title
A Phase II Trial of Continuous Low-Dose Temozolomide for Patients With Recurrent Malignant Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI), Weill Medical College of Cornell University, Schering-Plough

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary Determine the progression-free survival rate at 6 months in patients with recurrent glioblastoma multiforme or other malignant glioma treated with temozolomide. Secondary Determine the overall survival of patients treated with this drug. OUTLINE: Patients receive oral temozolomide once daily in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and every 2 months for 2 years for evaluation of markers of neo-angiogenesis. Samples are analyzed by protein expression, reverse-transcriptase PCR, ELISA, and western blot. (Samples are no longer being collected and tested as of 1/12/09)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Temozolomide
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
temozolomide
Intervention Type
Genetic
Intervention Name(s)
protein expression analysis
Intervention Type
Genetic
Intervention Name(s)
reverse transcriptase-polymerase chain reaction
Intervention Type
Other
Intervention Name(s)
diagnostic laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
immunoenzyme technique
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) Rate at 6 Months
Description
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.
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
All patients will have their tumor measurements recorded at baseline and at the time of each MRI scan. Lesions must be measured in two dimensions. The dose of gadolinium must be held constant from scan to scan. Macdonald criteria will be used for assessment of tumor response.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Omuro, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Kaley, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23243055
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs