Clinical trial · Interventional
SU5416 in Treating Patients With Recurrent Astrocytoma or Mixed Glioma That Has Not Responded to Radiation Therapy
A Phase I/II Trial of SU5416 in Patients With Recurrent High Grade Astrocytomas or Mixed Gliomas
NCT00004868CI-TRIAL-00033488completedPhase 1 / Phase 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)
RATIONALE: SU5416 may stop the growth of astrocytoma or glioma by stopping blood flow to the tumor. PURPOSE: Phase I/II trial to study the effectiveness of SU5416 in treating patients who have recurrent astrocytoma or mixed glioma that has not responded to previous radiation therapy.
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 |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| semaxanib | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven supratentorial malignant primary glioma, including: * Glioblastoma multiforme * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Anaplastic mixed oligoastrocytoma * Malignant astrocytoma not otherwise specified * Benign or malignant meningiomas, including brain and spinal meningiomas * Patients with meningiomas are excluded from phase II portion of study * Must have shown unequivocal evidence of tumor recurrence or progression by CT scan or MRI * Must have failed prior radiotherapy * Must have prestudy contrast MRI or contrast CT scan of brain on stable steroid dose within the past 14 days * Must be on stable (unchanged) dose of steroids for at least 5 days before scans * Phase II: * Must have completed radiotherapy at least 2 months prior to enrollment PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * More than 8 weeks Hematopoietic: * WBC at least 2,300/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 8 g/dL (transfusion allowed) Hepatic: * SGOT less than 2.5 times upper limit of normal * Bilirubin normal * No significant active hepatic disease Renal: * Creatinine less than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min * No significant active renal disease Cardiovascular: * No uncompensated coronary artery disease on ECG or physical examination * No history of myocardial infarction or severe/unstable angina within the past 6 months * No deep venous or arterial thrombosis within the past 3 months Pulmonary: * No pulmonary embolism within the past 3 months Other: * Not pregnant or nursing * Fertile patients must use effective contraception during and for 2 months after study * No other serious concurrent illness * No significant active psychiatric disease * No diabetes mellitus with severe peripheral vascular disease * No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No serious active infection * No other concurrent disease that would obscure toxic effects or dangerously alter drug metabolism PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior biologic therapy (e.g., interferon) and recovered * No concurrent immunotherapy Chemotherapy: * Phase I: * No more than 2 prior chemotherapy regimens for recurrent disease * Phase II: * No more than 1 prior chemotherapy regimen for recurrent disease * At least 2 weeks since prior vincristine * At least 6 weeks since prior nitrosoureas * At least 3 weeks since prior procarbazine * Recovered from prior chemotherapy * No concurrent chemotherapy Endocrine therapy: * See Disease Characteristics * At least 3 weeks since prior endocrine therapy (e.g., tamoxifen) and recovered Radiotherapy: * See Disease Characteristics * No concurrent radiotherapy Surgery: * Recovered from prior surgery * Recent prior resection of recurrent or progressive tumor allowed Other: * No other concurrent investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.