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
Recruitment status was Recruiting
Sponsor:
Oncology Institute of Southern Switzerland
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00637637
First received: March 14, 2008
Last updated: February 24, 2011
Last verified: December 2008
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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:
Genetics Home Reference related topics:
bladder cancer
breast cancer
mycosis fungoides
neuroblastoma
Sézary syndrome
U.S. FDA Resources
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) |
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
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: | CDR0000587517, IOSI-RO0402 |
| Study First Received: | March 14, 2008 |
| Last Updated: | February 24, 2011 |
| 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:
|
Neoplasm Metastasis Neoplastic Processes Neoplasms Pathologic Processes Indinavir Ritonavir 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 June 17, 2013