Trials / Completed
CompletedNCT00024570
Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma
Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma: Phase I/II Study
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 60 (planned)
- Sponsor
- INSYS Therapeutics Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
IL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a bacteria toxin). IL3-PE38QQR is a protein that exhibits cell killing activity against a variety of IL13 receptor-positive tumor cell lines indicating that it may show a therapeutic benefit. In reciprocal competition experiments, the interaction between IL13-PE38QQR and the IL13 receptors was shown to be highly specific for human glioma cells. IL13-PE38QQR will be infused in two courses of 96 hours each, eight weeks apart, directly into the malignant brain tumors of patients to determine the dose of drug these patients can tolerate. After that, the selected dose will be studied to give an estimate of the response rate, response duration, time to response, and survival after infusing that dose of IL13-PE38QQR into the recurrent malignant glioma.
Detailed description
OBJECTIVES: I. Determine the toxicities and maximum tolerated dose of IL13-PE38QQR delivered by continuous infusion into malignant glioma over 96 hours, in two courses eight weeks apart. II. Estimate the response rate, response duration, time to response, and survival after interstitial infusion of IL13-PE38QQR into recurrent malignant glioma. III. Describe the toxicities of interstitial infusion of IL13-PE38QQR at the selected dose. PROTOCOL OUTLINE: Patients are expected to receive two IL13-PE38QQR infusions at 8-week intervals. For each course, drug will be infused through each of two catheters; infusion rate will be held constant during a 96-hour infusion. In Phase I, the dose of IL13-PE38QQR will be increased by increasing the IL13-PE38QQR concentration in stepwise fashion, while holding infusion volume and duration constant. Three patients will be treated at each dose level until the maximum tolerated dose (MTD) is reached, and an additional three patients are treated at that level. In Phase II, patients will be treated at the selected MTD. PROJECTED ACCRUAL: In Phase I, up to 30 patients will be treated. In Phase II, up to 35 patients will be treated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IL13-PE38QQR | |
| PROCEDURE | targeted fusion protein therapy | |
| PROCEDURE | surgery |
Timeline
- Start date
- 2000-11-01
- Primary completion
- 2007-07-01
- Completion
- 2007-07-01
- First posted
- 2001-09-21
- Last updated
- 2014-11-14
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00024570. Inclusion in this directory is not an endorsement.