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	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific brain metastases Quality of Life	Drug: gadolinium texaphyrin	Phase III

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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)

--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

California
      Beckman Research Institute, City of Hope, Los Angeles,  California,  91010,  United States
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States
      Kaiser Permanente Medical Group, Los Angeles,  California,  90027,  United States
      Marin Oncology Associates, Inc., Greenbrae,  California,  94904,  United States
      Radiation Oncology Center - Sacramento, Sacramento,  California,  95816,  United States
Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80262,  United States
Florida
      Charlotte County Radiation Therapy Regional Center, Port Charlotte,  Florida,  33952,  United States
Georgia
      Emory Clinic, Atlanta,  Georgia,  30365,  United States
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5265,  United States
Louisiana
      Hematology and Oncology Services - Metairie, Metairie,  Louisiana,  70006,  United States
Massachusetts
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States
Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201,  United States
      Harper Hospital and Wayne State University, Detroit,  Michigan,  48201,  United States
Minnesota
      North Memorial Research Center, Minneapolis,  Minnesota,  55442-2900,  United States
      Veterans Affairs Medical Center - Minneapolis, Minneapolis,  Minnesota,  55417,  United States
New Jersey
      Cancer Institute of New Jersey, New Brunswick,  New Jersey,  08901,  United States
New Mexico
      New Mexico Oncology-Hematology, Albuquerque,  New Mexico,  87102,  United States
New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
Ohio
      Barrett Cancer Center, The University Hospital, Cincinnati,  Ohio,  45219,  United States
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States
Pennsylvania
      Abington Hematology Oncology Associates, Meadowbrook,  Pennsylvania,  18974,  United States
      Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107,  United States
      Mercy Hospital Cancer Center - Scranton, Scranton,  Pennsylvania,  18501,  United States
      Presbyterian-University Hospital, Pittsburgh,  Pennsylvania,  15213,  United States
Tennessee
      Thompson Cancer Survival Center, Knoxville,  Tennessee,  37916,  United States
      Vanderbilt Cancer Center, Nashville,  Tennessee,  37232-6838,  United States
Texas
      Scott and White Memorial Hospital, Temple,  Texas,  76508,  United States
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States
Washington
      Virginia Mason Medical Center, Seattle,  Washington,  98111,  United States
Wisconsin
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792,  United States
Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada
Canada, Ontario
      Cancer Care Ontario-Hamilton Regional Cancer Centre, Hamilton,  Ontario,  L8V 5C2,  Canada
      Princess Margaret Hospital, Toronto,  Ontario,  M5G 2M9,  Canada
Canada, Quebec
      Montreal General Hospital, Montreal,  Quebec,  H3G 1A4,  Canada

Study chairs or principal investigators

Markus Renschler,  Study Chair,  Pharmacyclics   

Study ID Numbers:  CDR0000066627; PCI-P120-9801; NCI-V98-1470; MSKCC-00088; UCLA-9808021
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003563
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08