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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Metastatic Cancer

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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 CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
University of Colorado Cancer CenterDenver, Colorado  80262
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Medical College of WisconsinMilwaukee, Wisconsin  53226
Beckman Research Institute, City of HopeLos Angeles, California  91010
Radiation Oncology Center - SacramentoSacramento, California  95816
Mercy Hospital Cancer Center - ScrantonScranton, Pennsylvania  18501
Virginia Mason Medical CenterSeattle, Washington  98111
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Scott and White Memorial HospitalTemple, Texas  76508
Thompson Cancer Survival CenterKnoxville, Tennessee  37916
Marin Oncology Associates, Inc.Greenbrae, California  94904
Kaiser Permanente Medical GroupLos Angeles, California  90027
Charlotte County Radiation Therapy Regional CenterPort Charlotte, Florida  33952
Emory ClinicAtlanta, Georgia  30365
Hematology and Oncology Services - MetairieMetairie, Louisiana  70006
Harper Hospital and Wayne State UniversityDetroit, Michigan  48201
North Memorial Research CenterMinneapolis, Minnesota  55442-2900
New Mexico Oncology-HematologyAlbuquerque, New Mexico  87102
Abington Hematology Oncology AssociatesMeadowbrook, Pennsylvania  18974
Presbyterian-University HospitalPittsburgh, Pennsylvania  15213