Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Brain Metastases

October 29, 2013 updated by: Pharmacyclics LLC.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

430

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WBRT
3 Gy of WBRT daily for a total of 10 days
Radiation: WBRT
3 GY of WBRT daily for a total of 10 days
Experimental: MGd
IV does of 5.0 mg/kg MGd plus WBRT
Radiation: WBRT
3 GY of WBRT daily for a total of 10 days
Drug: MGd
5.0 mg /kg MGd plus WBRT
Other Names:
  • MGd plus WBRT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmacyclics LLC.

Investigators

  • Study Chair: Markus Renschler, MD, Pharmacyclics LLC.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1998

Primary Completion (Actual)

September 1, 2001

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

April 29, 2004

First Posted (Estimate)

April 30, 2004

Study Record Updates

Last Update Posted (Estimate)

October 31, 2013

Last Update Submitted That Met QC Criteria

October 29, 2013

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066627
  • PCI-P120-9801
  • MSKCC-00088
  • UCLA-9808021
  • NCI-V98-1470

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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