External-Beam Radiation Therapy With or Without Indinavir and Ritonavir in Treating Patients With Brain Metastases

August 9, 2013 updated by: Oncology Institute of Southern Switzerland

Radiation Therapy in Combination With Indinavir / Ritonavir (Crixivan / Norvir) for the Treatment of Brain Metastases: a Randomized Phase II Study

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Indinavir and ritonavir may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether external-beam radiation therapy is more effective with or without indinavir and ritonavir in treating patients with brain metastases.

PURPOSE: This randomized phase II trial is studying external-beam radiation therapy alone to see how well it works compared to external-beam radiation therapy given together with indinavir and ritonavir in treating patients with brain metastases.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the efficacy, in terms of time to treatment failure at CNS level and 4-months treatment failure rate, in patients with brain metastases treated with external-beam radiotherapy in combination with indinavir sulfate and ritonavir versus external-beam radiotherapy alone.
  • Prospectively investigate the efficacy of a potentially antiangiogenic agent, indinavir sulfate.
  • Investigate the antineoplastic activity of indinavir sulfate in combination with ionizing radiation in cancer patients with metastatic disease to the brain.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo radiotherapy to the brain once daily, 5 days a week for 2 weeks (10 doses total). Patients also receive oral indinavir sulfate and oral ritonavir twice daily for 35 days beginning at day 1 of radiotherapy.
  • Arm II: Patients undergo radiotherapy to the brain once daily, 5 days a week for 2 weeks (10 doses total).

Patients complete quality of life questionnaires, including QOL-30 and the Mini Mental Status Examination, at baseline, 2 weeks after completion of radiotherapy, and at 1 and 3 months after completion of study treatment.

After completion of study treatment, patients are followed periodically for at least 4 months.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

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

  • Switzerland
      • Geneva, Switzerland, CH-1211
        • Recruiting
        • Hôpital Cantonal Universitaire de Genève
        • Contact:
          • Contact Person
          • Phone Number: 41-22-372-3270
      • Lugano, Switzerland, CH-6900
        • Recruiting
        • Oncology Institute of Southern Switzerland - Lugano
        • Contact:
          • Contact Person
          • Phone Number: 41-91-811-9157
      • Zurich, Switzerland, CH-8091
        • Recruiting
        • Universitaetsspital Zuerich
        • Contact:
          • Contact Person
          • Phone Number: 41-107-2004

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic cancer with brain metastases

    • Biopsy of brain metastases is not required

  • All cancer types allowed, except for the following:

    • Prostatic adenocarcinoma
    • Sarcoma
    • Melanoma
    • Germ cell carcinoma,
    • Small-cell lung cancer
  • Measurable disease by MRI of the brain
  • Not requiring immediate surgical decompression (may qualify after surgery, if remaining measurable brain lesions)

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2 (corresponds to recursive partitioning analysis groups I or II)
  • Life expectancy > 4 months
  • Able to understand the aim of trial and to comply with follow-up
  • No HIV seropositivity

PRIOR CONCURRENT THERAPY:

  • Prior dexamethasone allowed provided it is tapered before initiation of study radiotherapy
  • Not requiring cytotoxic treatment within 3 months after study radiotherapy
  • At least 1 week since prior and no concurrent phenytoin

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression-free survival at 6 months
Overall survival (OS)
Time to treatment failure in the brain (TTF) as determined by the radiological response rate
Radiological volumetric response to treatment
Local intracranial disease progression at 4 months

Secondary Outcome Measures

Outcome Measure
Improvement of symptoms
Time to symptom relapse or symptom progression
Duration of use of steroids
Duration of use of anticonvulsive drugs

Collaborators and Investigators

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

Sponsor

Oncology Institute of Southern Switzerland

Investigators

  • Principal Investigator: Ilja Ciernik, MD, Oncology Institute of Southern Switzerland

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

September 1, 2007

Primary Completion (Anticipated)

June 1, 2009

Study Registration Dates

First Submitted

March 14, 2008

First Submitted That Met QC Criteria

March 14, 2008

First Posted (Estimate)

March 18, 2008

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOSI-RO0402
  • CDR0000587517 (Registry Identifier: PDQ (Physician Data Query))

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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