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| Sponsor: | Pharmacyclics |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003563 |
Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Gadolinium texaphyrin may increase the effectiveness of radiation therapy by making tumor cells more sensitive to radiation. It is not yet known whether giving gadolinium texaphyrin with radiation therapy is more effective than radiation therapy alone in treating brain metastases.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without gadolinium texaphyrin in treating patients who have brain metastases.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Cancer |
Drug: motexafin gadolinium Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | Phase III Randomized Trial of Gadolinium Texaphyrin (PCI-0120) Injection as a Radiation Sensitizer in Patients Receiving Whole Brain Radiation Therapy for the Treatment of Brain Metastases |
| Estimated Enrollment: | 430 |
| Study Start Date: | August 1998 |
OBJECTIVES: I. Determine the safety of gadolinium texaphyrin administered prior to whole brain radiotherapy in patients with brain metastases. II. Compare the efficacy and toxicity of whole brain radiotherapy with or without gadolinium texaphyrin in these patients. III. Assess the quality of life of these patients.
OUTLINE: This is a randomized, two stage, multicenter study. Patients are stratified according to RTOG recursive partitioning analysis class (RPA class 1 vs class 2) and tumor type (breast vs lung vs other). Stage 1 (lead-in): All patients receive gadolinium texaphyrin IV over 5-10 minutes on the 10 days that they receive radiotherapy. Approximately 2-5 hours later, patients undergo whole brain radiotherapy. Stage 2 (randomization): Patients are randomized to one of two treatment arms. Patients in arm I undergo whole brain radiotherapy for 10 days. Patients in arm II receive gadolinium texaphyrin and radiotherapy as in stage 1. Quality of life is assessed on days 10 and 28, then monthly for 5 months, and then every 3 months thereafter. Patients are followed at day 28, then monthly for 5 months, and then every 3 months until death.
PROJECTED ACCRUAL: The lead-in phase will accrue at least 25-30 patients and the randomization phase will accrue 400 patients (200/arm) over a 12 month period.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven solid tumor with parenchymal brain metastasis Solitary metastasis eligible only if refused surgery or surgical resection deemed inappropriate No leptomeningeal metastases or subarachnoid spread of tumor No small cell lung cancer, germ cell tumors, lymphoma, or leukemia No liver metastases, unless from breast cancer No more than 1 site of extracranial metastases (multiple bone or lung metastases count as one site), unless from breast cancer Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 50,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST and ALT no greater than 2 times ULN Renal: Creatinine no greater than 2.0 mg/mL Other: No history of porphyria No history of G6PD deficiency HIV negative No other major medical illnesses No major psychiatric impairment Not pregnant or nursing Negative pregnancy test
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No chemotherapy during and for 2 weeks after gadolinium texaphyrin therapy Endocrine therapy: Concurrent hormonal therapy allowed Radiotherapy: No prior cranial radiation, including prior stereotactic radiosurgery No plan for radiosurgery or radiation boost following whole brain radiotherapy Concurrent radiotherapy allowed to other sites, except kidneys and liver Surgery: No prior subtotal or total resection of brain metastases (except biopsies)
Contacts and Locations
Hide Study Locations| United States, California | |
| Beckman Research Institute, City of Hope | |
| Los Angeles, California, United States, 91010 | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Kaiser Permanente Medical Group | |
| Los Angeles, California, United States, 90027 | |
| Marin Oncology Associates, Inc. | |
| Greenbrae, California, United States, 94904 | |
| Radiation Oncology Center - Sacramento | |
| Sacramento, California, United States, 95816 | |
| United States, Colorado | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80262 | |
| United States, Florida | |
| Charlotte County Radiation Therapy Regional Center | |
| Port Charlotte, Florida, United States, 33952 | |
| United States, Georgia | |
| Emory Clinic | |
| Atlanta, Georgia, United States, 30365 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5265 | |
| United States, Louisiana | |
| Hematology and Oncology Services - Metairie | |
| Metairie, Louisiana, United States, 70006 | |
| United States, Massachusetts | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
| Harper Hospital and Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, Minnesota | |
| North Memorial Research Center | |
| Minneapolis, Minnesota, United States, 55442-2900 | |
| Veterans Affairs Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55417 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, New Mexico | |
| New Mexico Oncology-Hematology | |
| Albuquerque, New Mexico, United States, 87102 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| United States, Ohio | |
| Barrett Cancer Center, The University Hospital | |
| Cincinnati, Ohio, United States, 45219 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Abington Hematology Oncology Associates | |
| Meadowbrook, Pennsylvania, United States, 18974 | |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Mercy Hospital Cancer Center - Scranton | |
| Scranton, Pennsylvania, United States, 18501 | |
| Presbyterian-University Hospital | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Tennessee | |
| Thompson Cancer Survival Center | |
| Knoxville, Tennessee, United States, 37916 | |
| Vanderbilt Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| United States, Texas | |
| Scott and White Memorial Hospital | |
| Temple, Texas, United States, 76508 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| United States, Washington | |
| Virginia Mason Medical Center | |
| Seattle, Washington, United States, 98111 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792 | |
| Canada, Alberta | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, Ontario | |
| Cancer Care Ontario-Hamilton Regional Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| Montreal General Hospital | |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Study Chair: | Markus Renschler, MD | Pharmacyclics |
More Information
| Study ID Numbers: | CDR0000066627, PCI-P120-9801, MSKCC-00088, UCLA-9808021, NCI-V98-1470 |
| Study First Received: | November 1, 1999 |
| Last Updated: | August 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003563 History of Changes |
| Health Authority: | United States: Federal Government |
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tumors metastatic to brain |
|
Photosensitizing Agents Neoplasms Neoplastic Processes Pathologic Processes Radiation-Sensitizing Agents Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Neoplasm Metastasis Motexafin gadolinium Dermatologic Agents Pharmacologic Actions |
