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

Primary Purpose

Cancer

Status
Unknown status
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
indinavir sulfate
ritonavir
radiation therapy
Sponsored by
Oncology Institute of Southern Switzerland
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring 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, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV hypopharyngeal cancer, stage IV inverted papilloma of the paranasal sinus and nasal cavity, stage IV laryngeal cancer, stage IV lip and oral cavity cancer, stage IV lymphoepithelioma of the nasopharynx, stage IV lymphoepithelioma of the oropharynx, stage IV mantle cell lymphoma, stage IV marginal zone lymphoma, stage IV midline lethal granuloma of the paranasal sinus and nasal cavity, stage IV mucoepidermoid carcinoma of the oral cavity, stage IV mycosis fungoides/Sezary syndrome, 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 IV small lymphocytic lymphoma, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV endometrial carcinoma, stage IV verrucous carcinoma of the larynx, stage IV verrucous carcinoma of the oral cavity, stage IVB vulvar cancer, stage IV Wilms tumor, stage IVB cervical cancer, stage IVB vaginal cancer, metastatic adult malignant fibrous histiocytoma of bone, metastatic childhood malignant fibrous histiocytoma of bone, metastatic gastrointestinal carcinoid tumor, metastatic parathyroid cancer, metastatic pheochromocytoma, metastatic squamous neck cancer with occult primary squamous cell carcinoma, metastatic squamous neck cancer with occult primary, metastatic transitional cell cancer of the renal pelvis and ureter, disseminated neuroblastoma, unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific, tongue cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Cantonal Universitaire de GeneveRecruiting
  • Oncology Institute of Southern Switzerland - LuganoRecruiting
  • UniversitaetsSpital ZuerichRecruiting

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

First Posted
March 14, 2008
Last Updated
August 9, 2013
Sponsor
Oncology Institute of Southern Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT00637637
Brief Title
External-Beam Radiation Therapy With or Without Indinavir and Ritonavir in Treating Patients With Brain Metastases
Official Title
Radiation Therapy in Combination With Indinavir / Ritonavir (Crixivan / Norvir) for the Treatment of Brain Metastases: a Randomized Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Oncology Institute of Southern Switzerland

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
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, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV hypopharyngeal cancer, stage IV inverted papilloma of the paranasal sinus and nasal cavity, stage IV laryngeal cancer, stage IV lip and oral cavity cancer, stage IV lymphoepithelioma of the nasopharynx, stage IV lymphoepithelioma of the oropharynx, stage IV mantle cell lymphoma, stage IV marginal zone lymphoma, stage IV midline lethal granuloma of the paranasal sinus and nasal cavity, stage IV mucoepidermoid carcinoma of the oral cavity, stage IV mycosis fungoides/Sezary syndrome, 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 IV small lymphocytic lymphoma, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV endometrial carcinoma, stage IV verrucous carcinoma of the larynx, stage IV verrucous carcinoma of the oral cavity, stage IVB vulvar cancer, stage IV Wilms tumor, stage IVB cervical cancer, stage IVB vaginal cancer, metastatic adult malignant fibrous histiocytoma of bone, metastatic childhood malignant fibrous histiocytoma of bone, metastatic gastrointestinal carcinoid tumor, metastatic parathyroid cancer, metastatic pheochromocytoma, metastatic squamous neck cancer with occult primary squamous cell carcinoma, metastatic squamous neck cancer with occult primary, metastatic transitional cell cancer of the renal pelvis and ureter, disseminated neuroblastoma, unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific, tongue cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
indinavir sulfate
Intervention Type
Drug
Intervention Name(s)
ritonavir
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Time to treatment failure in the brain (TTF) as determined by the radiological response rate
Title
Overall survival (OS)
Title
Radiological volumetric response to treatment
Title
Local intracranial disease progression at 4 months
Title
Progression-free survival at 6 months
Secondary Outcome Measure Information:
Title
Improvement of symptoms
Title
Time to symptom relapse or symptom progression
Title
Duration of use of steroids
Title
Duration of use of anticonvulsive drugs

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilja Ciernik, MD
Organizational Affiliation
Oncology Institute of Southern Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Cantonal Universitaire de Geneve
City
Geneva
ZIP/Postal Code
CH-1211
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
41-22-372-3270
Facility Name
Oncology Institute of Southern Switzerland - Lugano
City
Lugano
ZIP/Postal Code
CH-6900
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
41-91-811-9157
Facility Name
UniversitaetsSpital Zuerich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
41-107-2004

12. IPD Sharing Statement

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

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