Clinical trial · Interventional
Motexafin Gadolinium in Treating Patients With Glioblastoma Multiforme Who Are Undergoing Radiation Therapy to the Brain
A Phase I Trial To Evaluate Repetitive Intravenous Doses Of Gadolinium-Texaphyrin As A Radiosensitizer In Patients With Glioblastoma Multi Forme
NCT00032097CI-TRIAL-00001988completedPhase 1ClinicalTrials.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: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as motexafin gadolinium may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness motexafin gadolinium in treating patients with glioblastoma multiforme who are undergoing radiation therapy to the brain.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| motexafin gadolinium | Drug | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed supratentorial grade IV astrocytoma * Glioblastoma multiforme * Previously untreated disease * Measurable and contrast-enhancing tumor by MRI after incomplete resection/biopsy PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin no greater than 2.0 mg/dL * SGOT/SGPT no greater than 4 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 4 times ULN * PT/APTT normal Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No uncontrolled hypertension Other: * Mini mental state exam score at least 15 * No history of glucose-6-phosphate dehydrogenase deficiency or porphyria * No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of the breast * No serious infection * No other medical illness that would preclude study participation * No allergy to MRI contrast (e.g., motexafin gadolinium) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for up to 2 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy or immunotherapy for this disease, including any of the following: * Immunotoxins * Immunoconjugates * Antisense therapy * Peptide receptor antagonists * Interferons * Interleukins * Tumor-infiltrating lymphocytes * Lymphokine-activated killer cell therapy * Gene therapy Chemotherapy: * No prior chemotherapy for this disease Endocrine therapy: * Must be on a stable corticosteroid regimen (i.e., no increase within 5 days prior to treatment on this protocol) * No other prior hormonal therapy for this disease Radiotherapy: * No prior radiotherapy for this disease Surgery: * See Disease Characteristics * Recovered from prior surgery Other: * No other concurrent investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.