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- Klinische proef NCT00032097
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
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
OBJECTIVES:
- Determine the toxicity of 2 different schedules of motexafin gadolinium as a radiosensitizer in patients with glioblastoma multiforme receiving cranial radiotherapy.
- Determine the maximum tolerated doses of this drug on these 2 schedules in these patients.
- Determine the pharmacokinetic profile of this drug in these patients.
- Determine the biodistribution of this drug in both neoplastic tissue and normal brain parenchyma in these patients.
- Determine the effect and accumulation of this drug in both normal brain parenchyma and neoplastic tissue in these patients.
- Correlate the effect and accumulation of this drug in both normal brain parenchyma and neoplastic tissue with the pharmacokinetics of this drug in these patients.
OUTLINE: This is a multicenter, dose-escalation study of motexafin gadolinium (PCI-0120). Patients are sequentially assigned to 1 of 2 treatment groups.
- Group I: Patients receive PCI-0120 IV over 30-60 minutes once every other day for 6 weeks. Patients concurrently undergo cranial radiotherapy once daily 5 days a week for 6 weeks.
- Group II: Patients receive PCI-0120 IV over 30-60 minutes once daily concurrently during radiotherapy. Patients undergo cranial radiotherapy as in group I.
Cohorts of 3-6 patients in each group receive escalating doses of PCI-0120 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 1 month and then every 2 months thereafter.
PROJECTED ACCRUAL: Approximately 18-30 patients will be accrued for this study.
Studietype
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21231
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: James L. Pearlman, MD, H. Lee Moffitt Cancer Center and Research Institute
Studie record data
Bestudeer belangrijke data
Studie start
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het zenuwstelsel
- Neoplasmata per histologisch type
- Neoplasmata
- Neoplasmata per site
- Neoplasmata, glandulair en epitheel
- Astrocytoom
- Glioom
- Neoplasmata, neuro-epitheliaal
- Neuro-ectodermale tumoren
- Neoplasmata, kiemcellen en embryonaal
- Neoplasmata, zenuwweefsel
- Glioblastoom
- Neoplasmata van het zenuwstelsel
- Neoplasmata van het centrale zenuwstelsel
- Antineoplastische middelen
- Fotosensibiliserende middelen
- Dermatologische middelen
- Motexafin gadolinium
Andere studie-ID-nummers
- CDR0000069257
- NABTT-2116
- JHOC-NABTT-2116
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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