CancerPhase 2NCT00637637
External-Beam Radiation Therapy With or Without Indinavir and Ritonavir in Treating Patients With Brain Metastases
A Phase 2 study testing indinavir sulfate, ritonavir and radiation therapy in people with Cancer, run by Oncology Institute of Southern Switzerland at 3 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- indinavir sulfate, ritonavir and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Sep 2007to Jun 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites, 3 recruiting
- Recruiting
Hopital Cantonal Universitaire de Geneve
Geneva, CH-1211
Contact Person, 41-22-372-3270
- Recruiting
Oncology Institute of Southern Switzerland - Lugano
Lugano, CH-6900
Contact Person, 41-91-811-9157
- Recruiting
UniversitaetsSpital Zuerich
Zurich, CH-8091
Contact Person, 41-107-2004
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- indinavir sulfate, ritonavir, radiation therapy
- 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
- Medical subject headings
- Neoplasms, Brain Neoplasms, Adrenocortical Carcinoma, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Hodgkin Disease, Lymphoma, Large-Cell, Immunoblastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indinavir sulfateDrug
ritonavirDrug
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startSep 2007
- Primary completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncology Institute of Southern Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Ilja Ciernik, MD, Principal investigator, Oncology Institute of Southern Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637637
- Sponsor's protocol ID
- IOSI-RO0402
- Other IDs
- CDR0000587517
- Status last verified
- Dec 2008
- First submitted
- 14 Mar 2008
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Therapy in Combination With Indinavir / Ritonavir (Crixivan / Norvir) for the Treatment of Brain Metastases: a Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT00637637
- Acronym / sponsor ID
- IOSI-RO0402
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oncology Institute of Southern SwitzerlandUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jun 2009 (estimated)
- First posted
- 18 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| indinavir sulfate | Drug | – |
| ritonavir | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
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
4 secondary outcomes
Improvement of symptoms
Time to symptom relapse or symptom progression
Duration of use of steroids
Duration of use of anticonvulsive drugs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilja Ciernik, MD principal investigator
Oncology Institute of Southern Switzerland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing indinavir sulfate, ritonavir and radiation therapy in people with Cancer, run by Oncology Institute of Southern Switzerland at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to treatment failure in the brain (TTF) as determined by the radiological response rate. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.