Phase 2
N=47
Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma
Brain and Central Nervous System Tumors
Bottom Line
View on ClinicalTrials.gov: NCT00498927 ↗Enrolled (actual)
47
Serious AEs
29.8%
Results posted
Feb 2016
Primary outcome: Primary: Progression-free Survival (PFS) Rate at 6 Months — 19 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- temozolomide (Drug); protein expression analysis (Genetic); reverse transcriptase-polymerase chain reaction (Genetic); diagnostic laboratory biomarker analysis (Other); immunoenzyme technique (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) Rate at 6 Months |
19 | — |
| SECONDARY Overall Survival |
7 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00498927). 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.