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Phase IB/II Study of Gadolinium Texaphyrin (PCI-0120) Radiosensitization for Palliative Radiotherapy of Brain Metastases (Summary Last Modified 05/98)
Basic Trial Information
Objectives I. Estimate the maximum tolerated dose (MTD) of the radiosensitizer gadolinium texaphyrin (PCI-0120), and establish an appropriate intravenous dose for repetitive treatments in patients with brain metastases that require palliative radiotherapy. II. Establish a safety profile of PCI-0120 by evaluating an additional 20 patients at the MTD. III. Evaluate the accumulation of PCI-0120 in metastases and the tumor response to treatment. IV. Describe the dose-limiting toxicity of repetitive injections of PCI-0120 followed by radiotherapy in these patients. V. Determine the biolocalization of PCI-0120 in cancerous and normal tissue, and assess the change in tumor volume using the high (white) signal intensity produced by PCI-0120 on magnetic resonance imaging. VI. Determine the in vivo pharmacokinetics of PCI-0120 in patients treated at the MTD. Entry Criteria Disease Characteristics: Brain metastases (demonstrated by radiography) that require palliative radiotherapy Resected brain metastases, leptomeningeal metastases, and cerebrospinal fluid involvement allowed only on phase IB portion of study Prior/Concurrent Therapy: At least 4 weeks since cytotoxic chemotherapy (6 weeks since nitrosoureas) At least 14 days since prior investigational radiosensitizers No prior radiotherapy to planned treatment site Patient Characteristics: Age: 18 and over Performance status: 0-2 Life expectancy: At least 2 months Hematopoietic: WBC at least 3,000 AGC at least 1,500 Platelets greater than 100,000 Hepatic: Bilirubin less than 2 mg/dL AST/ALT less than twice normal Alkaline phosphatase less than twice normal PT and aPTT no more than 1.5 times normal Renal: Creatinine less than 1.5 mg/dL Neurological status: Neurologic function no greater than 2 Other: No contraindication to MRI and/or CT No medical or psychiatric condition that precludes informed consent No pregnant or nursing women Negative pregnancy test required of fertile patients Men should avoid pregnancy-inducing sexual activity while on study Able to comply with treatment and adequate follow-up Expected Enrollment Approximately 50 patients will be entered. Duration of study is expected to be 6-12 months. Outline Radiotherapy with Radiosensitization. External-beam whole-brain irradiation using at least 4 MV photons; with Gadolinium Texaphyrin, PCI-0120 (prior to each radiotherapy fraction). Trial Lead Organizations Pharmacyclics, Incorporated
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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