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Home > "G" Clinical Trials Conditions > Gadolinium Texaphyrin Plus Radiation Therapy in Treating Patients With Supratentorial Glioblastoma Multiforme  Gadolinium Texaphyrin Plus Radiation Therapy in Treating Patients With Supratentorial Glioblastoma Multiforme
Gadolinium Texaphyrin Plus Radiation Therapy in Treating Patients With Supratentorial Glioblastoma Multiforme
For Condition: adult glioblastoma multiforme
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Johns Hopkins Oncology Center
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as gadolinium texaphyrin may make tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness of gadolinium texaphyrin plus radiation therapy in treating patients who have supratentorial glioblastoma multiforme that has not been previously treated.
Details: OBJECTIVES: I. Evaluate the toxic effects of gadolinium texaphyrin administered to patients receiving cranial radiotherapy for glioblastoma multiforme. II. Determine the maximum tolerated dose of this regimen in these patients. III. Determine the pharmacokinetic profile of this regimen in these patients. IV. Determine the biodistribution of gadolinium texaphyrin in both neoplastic tissue and normal brain parenchyma. V. Evaluate the effect and accumulation of this regimen in normal brain parenchyma and neoplastic tissue by following the change in enhancing volume and percent change in signal intensity over time. PROTOCOL OUTLINE: This is an open label, multicenter study. Arm I: Patients receive radiotherapy once a day, 5 days a week, for 6 weeks. Gadolinium texaphyrin IV is administered every other day within 2-5 hours prior to radiotherapy. Patients are evaluated at 1 month, and if no more than 1 of 3 patients experiences unacceptable toxicity, 3 patients are entered on the imaging portion of the study. Once arm I has successfully entered 3 patients with acceptable toxicity profiles and 3 patients in the imaging portion of the study, patient enrollment begins for arm II. Arm II: Cohorts of 3-9 patients receive radiotherapy as in arm I and escalating doses of gadolinium texaphyrin IV administered within 2-5 hours prior to each radiation dose. The maximum tolerated dose (MTD) of gadolinium texaphyrin is defined as the dose at which no more than one third of the patients experience dose limiting toxicity. Arm III: Patients experiencing dose limiting toxicity in arm II requiring dose reduction below predetermined once a day limit receive gadolinium every other day, with radiotherapy as in arm II. The MTD is defined as in arm II. Arm IV: An additional 3 patients are enrolled at the MTD and enter the imaging portion of the study. Patients are followed for 1 month after final radiation therapy. PROJECTED ACCRUAL: At least 18 patients will be accrued for this study within 6 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed, previously untreated, supratentorial grade IV glioblastoma multiforme - Measurable and contrast enhancing disease on postoperative MRI --Prior/Concurrent Therapy-- - Biologic therapy: No prior immunotherapy for glioblastoma multiforme; No prior immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, tumor infiltrating lymphocytes, lymphokine activated killer cells, or gene therapy for glioblastoma multiforme - Chemotherapy: No prior chemotherapy for glioblastoma multiforme - Endocrine therapy: No prior hormonal therapy for glioblastoma multiforme; Stable corticosteroid regimen for at least 5 days prior to study - Radiotherapy: No prior radiotherapy for glioblastoma multiforme - Surgery: Recovered from postoperative complications - Other: No other concurrent investigational agents --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000/mm3; Absolute granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 10 g/dL - Hepatic: Bilirubin no greater than 2.0 mg/dL; Alkaline phosphatase no greater than 4 times upper limit of normal (ULN); SGOT or SGPT no greater than 4 times ULN; PT and PTT normal - Renal: Creatinine no greater than 1.5 mg/dL - Other: Not pregnant or nursing; Fertile patients must use effective contraception Negative pregnancy test; No serious infection or medical illness; No history of glucose-6-phosphate dehydrogenase deficiency; No known porphyria; No other prior malignancy within the past 5 years except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamesPearlman, Study Chair, Johns Hopkins Oncology Center
Additional Information:
Study ID Numbers: CDR0000066986; JHOC-NABTT-9712
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006452
Other Adult Glioblastoma Multiforme Studies:
1. Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme
2. Chemotherapy Followed by Radiation Therapy in Treating Patients With Malignant Glioma
3. Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma
4. Gadolinium Texaphyrin Plus Radiation Therapy in Treating Patients With Supratentorial Glioblastoma Multiforme
5. Immunotoxin Therapy in Treating Patients With Malignant Glioma
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Gadolinium Texaphyrin Plus Radiation Therapy in Treating Patients With Supratentorial Glioblastoma Multiforme
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