Clinical trial · Interventional
Ph. II Treatment of Adults w Primary Malignant Glioma w Irinotecan + Temozolomide
Phase II Treatment of Adults With Primary Malignant Glioma With Irinotecan Plus Temozolomide
NCT00616005CI-TRIAL-00015407completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Objective: To determine activity of combo of Irinotecan + Temozolomide To further characterize any toxicity associated w combo of Irinotecan + Temozolomide
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temodar and Irinotecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- 1
- description
- Pts taking EIAEDs
- interventionNames
- Drug: Temodar and Irinotecan
- type
- OTHER
- label
- 2
- description
- Pts not taking EIAEDs
- interventionNames
- Drug: Temodar and Irinotecan
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 6 months
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pts have histologically proven supratentorial GBM * Pts have newly diagnosed disease * There must be measurable disease on contrast-enhanced magnetic resonance imaging performed \<14 days before drug administration. Those who underwent resection must have MRI \<72 hrs/ \>14 days after surgery * Prior Surgical Resection/Biopsy: Although surgical resection is not required, pts must be treated \<42 days of surgery or biopsy * Age \>18 yrs * Karnofsky Performance Status \>70 percent * Serum creatinine \< 1.5 x ULN * Absolute neutrophil count \>1500 cells/microliter; platelet count \>100,000 cells/microliter * Serum SGOT \& total bilirubin \<2.5 x ULN * Signed informed consent, approved by IRB, will be obtained prior to initiating treatment * Pts must agree to practice effective birth control measures while on study \& for 2 months after completing therapy Exclusion Criteria: * Pregnant/breast feeding women / women/men w reproductive potential not practicing adequate contraception. This therapy may be associated w potential toxicity to fetus/child that exceeds minimum risks necessary to meet health needs of mother * Active infection requiring intravenous antibiotics * Known diagnosis of HIV infection * Pts w history of another primary malignancy that currently requires active intervention * Pts unwilling/unable to comply w protocol due to serious medical/psychiatric condition * Pts who underwent surgical resection for GBM \<2 weeks of start of treatment * Pts who have received prior chemo, biologic therapy, XRT, interstitial brachytherapy/radiosurgery to brain
References
Publications (0)
Data not yet available
No reference posted for this study.