NCT00637637

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 cancer

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Last Updated

August 12, 2013

Status Verified

December 1, 2008

Enrollment Period

1.8 years

First QC Date

March 14, 2008

Last Update Submit

August 9, 2013

Conditions

Cancer

Keywords

tumors metastatic to brainstage IV adenoid cystic carcinoma of the oral cavitystage IV adrenocortical carcinomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult Hodgkin lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult T-cell leukemia/lymphomastage IV anal cancerstage IV basal cell carcinoma of the lipstage IV bladder cancerstage IV borderline ovarian surface epithelial-stromal tumorstage IV breast cancerstage IV childhood anaplastic large cell lymphomastage IV childhood Hodgkin lymphomastage IV childhood large cell lymphomastage IV childhood liver cancerstage IV childhood lymphoblastic lymphomastage IV childhood small noncleaved cell lymphomastage IV chronic lymphocytic leukemiastage IV colon cancerstage IV cutaneous T-cell non-Hodgkin lymphomastage IV esophageal cancerstage IV esthesioneuroblastoma of the paranasal sinus and nasal cavitystage IV follicular thyroid cancerstage IV gastric cancerstage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV hypopharyngeal cancerstage IV inverted papilloma of the paranasal sinus and nasal cavitystage IV laryngeal cancerstage IV lip and oral cavity cancerstage IV lymphoepithelioma of the nasopharynxstage IV lymphoepithelioma of the oropharynxstage IV mantle cell lymphomastage IV marginal zone lymphomastage IV midline lethal granuloma of the paranasal sinus and nasal cavitystage IV mucoepidermoid carcinoma of the oral cavitystage IV mycosis fungoides/Sezary syndromestage IV nasopharyngeal cancerstage IV non-small cell lung cancerstage IV oropharyngeal cancerstage IV ovarian epithelial cancerstage IV pancreatic cancerstage IV papillary thyroid cancerstage IV paranasal sinus and nasal cavity cancerstage IV penile cancerstage IV prostate cancerstage IV rectal cancerstage IV renal cell cancerstage IV salivary gland cancerstage IV small lymphocytic lymphomastage IV squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the larynxstage IV squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the nasopharynxstage IV squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV endometrial carcinomastage IV verrucous carcinoma of the larynxstage IV verrucous carcinoma of the oral cavitystage IVB vulvar cancerstage IV Wilms tumorstage IVB cervical cancerstage IVB vaginal cancermetastatic adult malignant fibrous histiocytoma of bonemetastatic childhood malignant fibrous histiocytoma of bonemetastatic gastrointestinal carcinoid tumormetastatic parathyroid cancermetastatic pheochromocytomametastatic squamous neck cancer with occult primary squamous cell carcinomametastatic squamous neck cancer with occult primarymetastatic transitional cell cancer of the renal pelvis and ureterdisseminated neuroblastomaunspecified adult solid tumor, protocol specificunspecified childhood solid tumor, protocol specifictongue cancer

Outcome Measures

Primary Outcomes (5)

  • Time to treatment failure in the brain (TTF) as determined by the radiological response rate

  • Overall survival (OS)

  • Radiological volumetric response to treatment

  • Local intracranial disease progression at 4 months

  • Progression-free survival at 6 months

Secondary Outcomes (4)

  • Improvement of symptoms

  • Time to symptom relapse or symptom progression

  • Duration of use of steroids

  • Duration of use of anticonvulsive drugs

Interventions

indinavir sulfateDRUG
ritonavirDRUG
radiation therapyRADIATION

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Hopital Cantonal Universitaire de Geneve

Geneva, CH-1211, Switzerland

RECRUITING

Oncology Institute of Southern Switzerland - Lugano

Lugano, CH-6900, Switzerland

RECRUITING

UniversitaetsSpital Zuerich

Zurich, CH-8091, Switzerland

RECRUITING

MeSH Terms

Conditions

NeoplasmsBrain NeoplasmsAdrenocortical CarcinomaBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaAnus NeoplasmsUrinary Bladder NeoplasmsBreast NeoplasmsLymphoma, Large-Cell, AnaplasticDendritic Cell Sarcoma, InterdigitatingLeukemia, Lymphocytic, Chronic, B-CellColonic NeoplasmsLymphoma, T-Cell, CutaneousEsophageal NeoplasmsEsthesioneuroblastoma, OlfactoryAdenocarcinoma, FollicularStomach NeoplasmsLymphoma, FollicularHypopharyngeal NeoplasmsLaryngeal NeoplasmsMouth NeoplasmsLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneMycosis FungoidesSezary SyndromeNasopharyngeal NeoplasmsCarcinoma, Non-Small-Cell LungOropharyngeal NeoplasmsCarcinoma, Ovarian EpithelialPancreatic NeoplasmsThyroid Cancer, PapillaryPenile NeoplasmsProstatic NeoplasmsRectal NeoplasmsCarcinoma, Renal CellSalivary Gland NeoplasmsSquamous Cell Carcinoma of Head and NeckEndometrial NeoplasmsVulvar NeoplasmsWilms TumorUterine Cervical NeoplasmsVaginal NeoplasmsHistiocytoma, Malignant FibrousParathyroid NeoplasmsPheochromocytomaTongue Neoplasms

Interventions

IndinavirRitonavirRadiotherapy

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeAdrenal Cortex NeoplasmsAdrenal Gland NeoplasmsEndocrine Gland NeoplasmsAdrenal Cortex DiseasesAdrenal Gland DiseasesEndocrine System DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphomaLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLeukemiaHematologic DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphoma, T-CellHistiocytic Disorders, MalignantHistiocytosisLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsColonic DiseasesHead and Neck NeoplasmsEsophageal DiseasesNeuroblastomaNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueOlfactory Nerve DiseasesCranial Nerve DiseasesStomach DiseasesPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsMouth DiseasesNasopharyngeal DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsThoracic NeoplasmsLung DiseasesOvarian NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGenital DiseasesGonadal DisordersPancreatic DiseasesAdenocarcinoma, PapillaryThyroid NeoplasmsThyroid DiseasesGenital Neoplasms, MaleGenital Diseases, MalePenile DiseasesProstatic DiseasesKidney NeoplasmsKidney DiseasesSalivary Gland DiseasesCarcinoma, Squamous CellUterine NeoplasmsUterine DiseasesVulvar DiseasesNeoplasms, Complex and MixedNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesUterine Cervical DiseasesVaginal DiseasesHistiocytomaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueSarcomaParathyroid DiseasesParagangliomaNeuroendocrine TumorsTongue Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesSulfur CompoundsOrganic ChemicalsAzolesTherapeutics

Study Officials

  • Ilja Ciernik, MD

    Oncology Institute of Southern Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2008

First Posted

March 18, 2008

Study Start

September 1, 2007

Primary Completion

June 1, 2009

Last Updated

August 12, 2013

Record last verified: 2008-12

Locations

CH(3)