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CompletedNCT00313729Updated Feb 7, 2019Results posted

Temozolomide in Treating Patients With Low-Grade Glioma

A Phase 2 interventional study of temozolomide in CNS Tumor, Adult, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2019-02-07.

Sponsored by University of California, San Francisco · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
18 Years to 120 Years
Sex
All
01

Study 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 supratentorial low-grade glioma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the efficacy of temozolomide, defined as response rate (complete and partial response), in patients with supratentorial mixed low-grade glioma.

Secondary

  • Assess the safety profile of temozolomide in patients with supratentorial low-grade glioma.
  • Assess the time to tumor progression in patients treated with temozolomide.

OUTLINE: Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

02

Conditions studied

  • CNS Tumor, Adult

Keywords

  • adult oligodendroglioma
  • adult mixed glioma
  • adult diffuse astrocytoma
  • adult pilocytic astrocytoma
  • adult pineal gland astrocytoma
03

In context

Glioma

1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.

This study's enrollment of 120 is above the median of 32 across 1,065 interventional studies indexed under Glioma.

Browse Glioma studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically proven supratentorial low-grade (grade II) glioma of any of the following histologic subtypes:

    • Oligodendroglioma
    • Astrocytoma
    • Oligoastrocytoma

  • Has undergone surgical resection or biopsy within 35 days after diagnosis of low-grade glioma

    • Study treatment must begin between 14 days and 4 months after surgical resection or biopsy
  • Evaluable disease by gadolinium-MRI

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 10 g/dL
  • Creatinine \< 1.5 times upper limit of normal (ULN)
  • BUN \< 1.5 times ULN
  • Bilirubin \< 1.5 times ULN
  • SGOT \< 2.5 times ULN
  • Alkaline phosphatase \< 2 times ULN
  • Life expectancy > 12 weeks
  • No nonmalignant systemic disease resulting in the patient being a poor medical risk
  • No acute infection requiring intravenous antibiotics
  • No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction)

  • No other concurrent malignancies except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin

    • Prior malignancies must be in remission for ≥ 5 years
  • No known HIV positivity
  • No AIDS-related illness
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior radiotherapy, interstitial brachytherapy, or radiosurgery for low-grade glioma
  • No prior biological therapy or chemotherapy for low-grade glioma
  • No other concurrent chemotherapy
  • No concurrent radiotherapy or biological therapy
  • No concurrent prophylactic growth factors
  • No concurrent epoetin alfa
  • No other concurrent investigational drugs
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Temozolomide

    Temozolomide

    Drug: temozolomide

Interventions

  • Drugtemozolomide

    Chemotherapy

    Also known as: Temodar

06

What researchers measure

Primary outcomes

  1. Response Rate (Complete and Partial Response)

    Assessment of treatment response was determined by MRI in conjunction with neurological examination and steroid requirement assessment derived from Macdonald's criteria. Complete response was defined as complete disappearance of lesion on consecutive MRI scans with stable or improved neuro exam and steroids. Partial response was defined as a 50% reduction in lesion size or that tumor burden was "definitely better" than prior scan with stable or improved neuro exam and steroids.

    Time frame: 12 months

Secondary outcomes

  1. Time to Tumor Progression

    Progressive disease was defined as definite enlargement of any existing lesion or any new lesion based on modified Macdonald's criteria.

    Time frame: time from registration until date of the first documented progression, an average of 1 year

  2. Safety Profile

    Number of participants with treatment related grade 2-4 adverse events as defined by CTCAE 3.0

    Time frame: Time from registration up to 13 months

07

Results

Posted Jan 23, 2019

Participant flow

Participant flow — Overall Study
MilestoneSingle Arm Study of Temozolomide for LGG Patients
Started120
Completed120
Not completed0

Outcome measures

PrimaryResponse Rate (Complete and Partial Response)

Assessment of treatment response was determined by MRI in conjunction with neurological examination and steroid requirement assessment derived from Macdonald's criteria. Complete response was defined as complete disappearance of lesion on consecutive MRI scans with stable or improved neuro exam and steroids. Partial response was defined as a 50% reduction in lesion size or that tumor burden was "definitely better" than prior scan with stable or improved neuro exam and steroids.

Time frame:
12 months
Reported as:
Count of participants · Participants
Response Rate (Complete and Partial Response)
ParticipantsTemozolomide
Response Rate (Complete and Partial Response)7
SecondaryTime to Tumor Progression

Progressive disease was defined as definite enlargement of any existing lesion or any new lesion based on modified Macdonald's criteria.

Time frame:
time from registration until date of the first documented progression, an average of 1 year
Reported as:
Median · years
Time to Tumor Progression
yearsTemozolomide
Time to Tumor Progression3.8 (3.0 to 5.0)
SecondarySafety Profile

Number of participants with treatment related grade 2-4 adverse events as defined by CTCAE 3.0

Time frame:
Time from registration up to 13 months
Reported as:
Count of participants · Participants
Safety Profile
ParticipantsTemozolomide
Safety Profile12

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Temozolomide—17/120 (14.2%)31/120 (25.8%)
Most frequent serious events
Most frequent serious events
EventTemozolomide
seizureNervous system disorders6/120
HeadacheNervous system disorders3/120
NeutropeniaBlood and lymphatic system disorders2/120
Neutrophils/granulocytes (ANC)Blood and lymphatic system disorders1/120
Thrombocytopenia (platelets)Blood and lymphatic system disorders1/120
Infection with unknown ANCInfections and infestations1/120
HydrocephalusNervous system disorders1/120
VomitingGastrointestinal disorders1/120
DeathNervous system disorders1/120
Most frequent other events
Showing 10 of 36
Most frequent other events
EventTemozolomide
NauseaGastrointestinal disorders11/120
FatigueMetabolism and nutrition disorders9/120
ConstipationGastrointestinal disorders8/120
Leukocytes (total WBC)Blood and lymphatic system disorders8/120
SeizuresNervous system disorders7/120
Neutrophils/granulocytes (ANC/AGC)Blood and lymphatic system disorders6/120
SGPT (ALT) (serum glutamic pyruvic transaminase)Metabolism and nutrition disorders5/120
VomitingGastrointestinal disorders5/120
LymphopeniaBlood and lymphatic system disorders5/120
PlateletsBlood and lymphatic system disorders5/120

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Temozolomide
<=18 years0
Between 18 and 65 years119
>=65 years1
Sex: Female, Male
Sex: Female, Male(Participants)Temozolomide
Female53
Male67
08

Study locations

1 site
  • UCSF Helen Diller Family Comprehensive Cancer Center
    San Francisco, California 94115, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00313729
Lead sponsor
University of California, San Francisco
Responsible party
Susan Chang (MD, University of California, San Francisco) — Principal investigator
First posted
Apr 12, 2006
Start date
May 1999
Primary completion
Sep 25, 2014
Completion
Jun 12, 2017
Results posted
Jan 23, 2019
Last update
Feb 7, 2019

Study contacts

Susan M. Chang, MD
study chair · University of California, San Francisco

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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