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
18 Years
N/A
Both
Metastatic Cancer
Trial Information
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
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.
Inclusion Criteria
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Markus Renschler, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Pharmacyclics
Authority:
United States: Federal Government
Study ID:
CDR0000066627
NCT ID:
NCT00003563
Start Date:
August 1998
Completion Date:
Related Keywords:
- Metastatic Cancer
- tumors metastatic to brain
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| University of Colorado Cancer Center | Denver, Colorado 80262 |
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
| Vanderbilt Cancer Center | Nashville, Tennessee 37232-6838 |
| Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
| Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
| Beckman Research Institute, City of Hope | Los Angeles, California 91010 |
| Radiation Oncology Center - Sacramento | Sacramento, California 95816 |
| Mercy Hospital Cancer Center - Scranton | Scranton, Pennsylvania 18501 |
| Virginia Mason Medical Center | Seattle, Washington 98111 |
| University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
| Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
| Scott and White Memorial Hospital | Temple, Texas 76508 |
| Thompson Cancer Survival Center | Knoxville, Tennessee 37916 |
| Marin Oncology Associates, Inc. | Greenbrae, California 94904 |
| Kaiser Permanente Medical Group | Los Angeles, California 90027 |
| Charlotte County Radiation Therapy Regional Center | Port Charlotte, Florida 33952 |
| Emory Clinic | Atlanta, Georgia 30365 |
| Hematology and Oncology Services - Metairie | Metairie, Louisiana 70006 |
| Harper Hospital and Wayne State University | Detroit, Michigan 48201 |
| North Memorial Research Center | Minneapolis, Minnesota 55442-2900 |
| New Mexico Oncology-Hematology | Albuquerque, New Mexico 87102 |
| Abington Hematology Oncology Associates | Meadowbrook, Pennsylvania 18974 |
| Presbyterian-University Hospital | Pittsburgh, Pennsylvania 15213 |
