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NCT00498927 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2016-02-29

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression-free Survival (PFS) Rate at 6 Months

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outcome · POSTED

Overall Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. 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 Names
    1. Drug: temozolomide
    2. Genetic: protein expression analysis
    3. Genetic: reverse transcriptase-polymerase chain reaction
    4. Other: diagnostic laboratory biomarker analysis
    5. Other: immunoenzyme technique
    label
    Temozolomide
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Temozolomide
    name
    temozolomide
    type
    DRUG
  2. arm Group Labels
    1. Temozolomide
    name
    protein expression analysis
    type
    GENETIC
  3. arm Group Labels
    1. Temozolomide
    name
    reverse transcriptase-polymerase chain reaction
    type
    GENETIC
  4. arm Group Labels
    1. Temozolomide
    name
    diagnostic laboratory biomarker analysis
    type
    OTHER
  5. arm Group Labels
    1. Temozolomide
    name
    immunoenzyme technique
    type
    OTHER
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
47
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. 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.
    measure
    Progression-free Survival (PFS) Rate at 6 Months
    time Frame
    at 6 months
secondary Outcomes
  1. 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.
    measure
    Overall Survival
    time Frame
    2 years
Full 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)
Source references
references
  1. 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.
    pmid
    23243055
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      payload
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        exact text
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      query cond
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice