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

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ClinicalTrials.gov Identifier: NCT00637637
Recruitment Status : Unknown
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : March 18, 2008
Last Update Posted : August 12, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cancer Drug: indinavir sulfate Drug: ritonavir Radiation: radiation therapy Phase 2

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Radiation Therapy in Combination With Indinavir / Ritonavir (Crixivan / Norvir) for the Treatment of Brain Metastases: a Randomized Phase II Study
Study Start Date : September 2007
Estimated Primary Completion Date : June 2009





Primary Outcome Measures :
  1. Time to treatment failure in the brain (TTF) as determined by the radiological response rate
  2. Overall survival (OS)
  3. Radiological volumetric response to treatment
  4. Local intracranial disease progression at 4 months
  5. Progression-free survival at 6 months

Secondary Outcome Measures :
  1. Improvement of symptoms
  2. Time to symptom relapse or symptom progression
  3. Duration of use of steroids
  4. Duration of use of anticonvulsive drugs


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00637637


Locations
Switzerland
Hopital Cantonal Universitaire de Geneve Recruiting
Geneva, Switzerland, CH-1211
Contact: Contact Person    41-22-372-3270      
Oncology Institute of Southern Switzerland - Lugano Recruiting
Lugano, Switzerland, CH-6900
Contact: Contact Person    41-91-811-9157      
UniversitaetsSpital Zuerich Recruiting
Zurich, Switzerland, CH-8091
Contact: Contact Person    41-107-2004      
Sponsors and Collaborators
Oncology Institute of Southern Switzerland
Investigators
Principal Investigator: Ilja Ciernik, MD Oncology Institute of Southern Switzerland

ClinicalTrials.gov Identifier: NCT00637637     History of Changes
Other Study ID Numbers: IOSI-RO0402
CDR0000587517 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: March 18, 2008    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: December 2008

Keywords provided by National Cancer Institute (NCI):
tumors metastatic to brain
stage IV anal cancer
stage IV bladder cancer
stage IV borderline ovarian surface epithelial-stromal tumor
stage IV breast cancer
stage IV childhood liver cancer
stage IV colon cancer
stage IV esophageal cancer
stage IV follicular thyroid cancer
stage IV gastric cancer
stage IV hypopharyngeal cancer
stage IV laryngeal cancer
stage IV lip and oral cavity cancer
stage IV nasopharyngeal cancer
stage IV non-small cell lung cancer
stage IV oropharyngeal cancer
stage IV ovarian epithelial cancer
stage IV pancreatic cancer
stage IV papillary thyroid cancer
stage IV paranasal sinus and nasal cavity cancer
stage IV penile cancer
stage IV prostate cancer
stage IV rectal cancer
stage IV renal cell cancer
stage IV salivary gland cancer
stage IVB vulvar cancer
stage IV Wilms tumor
stage IVB cervical cancer
stage IVB vaginal cancer
metastatic gastrointestinal carcinoid tumor

Additional relevant MeSH terms:
Ritonavir
Indinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors