Phase 2
N=120
Temozolomide in Treating Patients With Low-Grade Glioma
CNS Tumor, Adult
Bottom Line
View on ClinicalTrials.gov: NCT00313729 ↗Enrolled (actual)
120
Serious AEs
14.2%
Results posted
Jan 2019
Primary outcome: Primary: Response Rate (Complete and Partial Response) — 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- temozolomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate (Complete and Partial Response) |
7 | — |
| SECONDARY Time to Tumor Progression |
3.8 | — |
| SECONDARY Safety Profile |
12 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT00313729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.