Clinical trial · Interventional
Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma
A Single-Center, Open-Label, Phase II, Safety, Pharmacokinetic and Efficacy of Panzem Nanocrystal Colloidal Dispersion Administered Orally to Patients With Recurrent Glioblastoma Multiforme
NCT00306618CI-TRIAL-00001831completedPhase 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)
This single-center, open-label, phase 2 study will evaluate the anti-tumor activity, as well as the safety and pharmacokinetics, of Panzem (2-methoxyestradiol, 2ME2) Nanocrystal Colloidal Dispersion (NCD) administered in patients with recurrent glioblastoma multiforme (GBM)
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 |
|---|---|---|---|
| Recurrent Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Panzem Nanocrystal Colloidal Dispersion | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 6 month progression free survival and median overall survival
- timeFrame
- time of progression; survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of a 1st or 2nd recurrent/progressive primary WHO grade IV malignant glioma (glioblastoma multiforme or gliosarcoma). * 18 years or older * An interval of at least 2 weeks between prior surgical resection or any major surgery or 4 weeks between prior radiotherapy or chemotherapy (except nitrosoureas which require 6 weeks) * Karnofsky performance score equal to or greater than 70% * Hematocrit greater than 29%, absolute neutrophil count greater than 1,500 cells/micro liters, platelets greater than 100,000 cells/ micro liters * Serum creatinine less than 1.5 X upper limit of normal (ULN), serum SGOT less than 2.5 X ULN; and bilirubin less than 1.5 times ULN * Signed informed consent form and authorization for use and disclosure of protected health information approved by the IRB prior to patient entry * Agree to use effective contraceptive methods Exclusion Criteria: * Current, active systemic bleeding or excessive risk of bleeding * Be pregnant or lactating; not employing effective birth control * Concurrent severe and/or uncontrolled medical disease * Impairment of gastrointestinal (GI) function/disease * Requirement for therapy with coumadin (warfarin sodium) * Patient is less than 5 years free of another primary malignancy * Patients unwilling to or unable to comply with the protocol * Grade 2 or greater peripheral sensory neuropathy
References
Publications (0)
Data not yet available
No reference posted for this study.