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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00637637
First received: March 14, 2008
Last updated: August 9, 2013
Last verified: December 2008
  Purpose

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 Intervention Phase
Cancer
Drug: indinavir sulfate
Drug: ritonavir
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to treatment failure in the brain (TTF) as determined by the radiological response rate [ Designated as safety issue: No ]
  • Overall survival (OS) [ Designated as safety issue: No ]
  • Radiological volumetric response to treatment [ Designated as safety issue: No ]
  • Local intracranial disease progression at 4 months [ Designated as safety issue: No ]
  • Progression-free survival at 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of symptoms [ Designated as safety issue: No ]
  • Time to symptom relapse or symptom progression [ Designated as safety issue: No ]
  • Duration of use of steroids [ Designated as safety issue: No ]
  • Duration of use of anticonvulsive drugs [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2007
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00637637     History of Changes
Other Study ID Numbers: IOSI-RO0402, CDR0000587517
Study First Received: March 14, 2008
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
tumors metastatic to brain
stage IV adenoid cystic carcinoma of the oral cavity
stage IV adrenocortical carcinoma
stage IV adult Burkitt lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult Hodgkin lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV adult T-cell leukemia/lymphoma
stage IV anal cancer
stage IV basal cell carcinoma of the lip
stage IV bladder cancer
stage IV borderline ovarian surface epithelial-stromal tumor
stage IV breast cancer
stage IV childhood anaplastic large cell lymphoma
stage IV childhood Hodgkin lymphoma
stage IV childhood large cell lymphoma
stage IV childhood liver cancer
stage IV childhood lymphoblastic lymphoma
stage IV childhood small noncleaved cell lymphoma
stage IV chronic lymphocytic leukemia
stage IV colon cancer
stage IV cutaneous T-cell non-Hodgkin lymphoma
stage IV esophageal cancer
stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage IV follicular thyroid cancer
stage IV gastric cancer
stage IV grade 1 follicular lymphoma

Additional relevant MeSH terms:
Ritonavir
Indinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014