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Ribavirin

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Group 1: Inhaled form of Ribavirin 60 milligrams/milliliter 3 times/day for 3 hours for up to 10 days.

Group 2: Ribavirin Capsules 20 mg/kg orally 3 times/day for up to 10 days.

Modified schedule of 60 milligrams/milliliter for 3-hour period 3 times/day for at least 5 days by aerosolization via a SPAG-2 generator via a face mask.

One time loading dose of 10 mg/kg oral dose then 20 mg/kg orally (rounded to the nearest 200 mg dose) divided into three doses per day (max 1800 mg/day).

Roy F. Chemaly, MD

The goal of this clinical research study is to learn if ribavirin can help to control RSV in patients with immune systems that have been weakened by a stem cell transplant. Researchers also want to compare the effectiveness of the drug when it is given by mouth to when it is inhaled. The safety of the drug in both methods of delivery will be studied.

Ribavirin is designed to prevent the RSV virus from making more copies of itself in the body.

Study Groups:

If you are found to be eligible to take part in this study and the study doctor thinks that the disease requires treatment at this time, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group:

* If you are in Group 1, you will receive the inhaled form of ribavirin. You will inhale ribavirin 3 times a day for 3 hours each time in a tent in a hospital room. You will receive the drug for up to 10 days.
* If you are in Group 2, you will take capsules of ribavirin 3 times a day for up to 10 days.

If the study doctor does not think that the disease requires treatment at this time, you will be assigned to Group 3. If you are in Group 3, you will not receive treatment with ribavirin, but you will have the same tests and procedures at the study visits described below.

Study Visits:

At all study visits, you will be asked about how you are feeling, about any side effects or symptoms you may be having, and about any other drugs you may be taking.

On Day 3 (+/- 1 day):

* You will have a physical exam, including measurement of your vital signs
* Your nasal passages will be checked for RSV.

On Days 7 and 14 (+/- 1 day):

* Blood (about 2 teaspoons) will be drawn for routine tests.
* You will have a physical exam, including measurement of your vital signs
* Your nasal passages will be checked for RSV.

Length of Study:

If you are in Groups 1 or 2, you will receive the study drug for up to 10 days. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. If your doctor thinks you need treatment longer than 10 days, you will receive that as part of your routine care. This may mean changing to receiving the drug in inhaled form if you began the study receiving it by mouth.

All participants will have end-of-study and follow-up visits, as described below.

End-of-Study Visit:

If you are in Groups 1 or 2, the end-of-study visit will be about 14 days after your last dose of the study drug. If you are in Group 3, the end-of-study visit will take place at about Day 21. The following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs.
* Blood (about 4 teaspoons) will be drawn for routine tests and to check for RSV antibodies.
* Your nasal passages will be checked for RSV.
* You will be asked about how you are feeling, about any side effects or symptoms you may be having, and about any drugs you may be taking.

Follow-Up Visit:

About 6 to 10 weeks after your last dose of study drug, you will have a pulmonary function test to check your lung function.

This is an investigational study. Ribavirin is FDA approved and commercially available for the treatment of hepatitis C when given by mouth, and for severe RSV in children when inhaled. Giving the drug to adults with weak immune systems after a stem cell transplant is investigational.

Up to 96 patients will take part in this study. All will be enrolled at MD Anderson.

Respiratory Syncytial Virus - RSV Protocol

An Open Label Randomized Controlled Trial To Prevent the Progression of Respiratory Syncytial Virus Upper Respiratory Tract Infection to Lower Respiratory Tract Infection in Patients After Hematopoietic Stem Cell Transplant

Patient who developed signs of lower respiratory tract infection

M.D. Anderson Cancer Center

Ribavirin Capsules 20 mg/kg orally 3 times/day for up to 10 days.

Oral Ribavirin

Inhaled form of Ribavirin 60 milligrams/milliliter 3 times/day for 3 hours for up to 10 days.

Inhaled Ribavirin

No Ribavirin

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

One patient from the Oral ribavarin group withdrew consent.

Roy F. Chemaly, MD,MPH- Professor, Infectious Diseases

Percentage of Participants With Progression to Lower Respiratory Tract Infection (LRI)

Ribavirin Capsules 20 mg/kg orally 3 times/day for up to 10 days.

Ribavirin: One time loading dose of 10 mg/kg oral dose then 20 mg/kg orally (rounded to the nearest 200 mg dose) divided into three doses per day (max 1800 mg/day).

Overall Study

Hematologic Neoplasms

Hematologic Diseases

Aerosolized Ribavirin 6 grams over 18 hours every 24 hours

Aerosolized Ribavirin 2 grams over 3 hours every 8 hours

Arm 1 = 6 Grams Over 18 hours Every 24 Hours

Arm 2 = 2 Grams Over 3 Hours Every 8 Hours.

Primary Objectives:

1. To determine whether aerosolized ribavirin is effective when given at an intermittent dose over 3 hours every 8 hours for therapy of RSV upper respiratory tract infection (URI) and whether it can prevent progression to pneumonia.
2. To determine the effect of this regimen on persistence of viral shedding.

Ribavirin is the drug that is normally given to treat upper respiratory infections caused by RSV. The drug is only effective when inhaled as an aerosol. This treatment requires the patient to be in a tent and inhale the medication. The usual method for administering this drug has been to inhale the medication continuously over 18 hours. In this study, the same total dose of the medication will be used, however, treatment will be for 3 hours every 8 hours.

As part of your standard care, before treatment you will have blood drawn (around 2 teaspoons) for routine blood tests. You will have a washing from your throat and nose collected. For this procedure, around 1 teaspoon of saline will be sprayed into each nostril and you will blow your nose into a cup. You will have a swab of the nose and throat. You will also have a chest x-ray to check on the status of the disease. Women who are able to have children must have a negative blood or urine pregnancy test.

Before treatment, you will be randomly assigned (as in the toss of a coin) to one of two groups. Participants in one group will receive treatment with ribavirin over 3 hours every 8 hours. Participants in the other group will receive treatment using the standard treatment schedule, ribavirin over 18 hours every 24 hours.

For both groups, the drug will be administered as an aerosol using a face mask. This will require you to be in a tent while you are receiving therapy. Treatment will last between 5 and 10 days. This will require hospitalization. In addition to ribavirin treatment, you will also receive Xopenex inhalation therapy every 6 - 8 hours. Xopenex is a drug designed to make breathing easier. We may need to use another breathing treatment, albuterol inhalation therapy for one time if needed, directly after receiving ribavirin to make breathing easier.

Every 2-4 days during treatment you will have blood collected (around 2 teaspoons) for routine tests. On Days 3 and 7 of treatment (+/- 2 days), you will have a repeat throat and nose washings/swabs. The washings and swabs will then be repeated once a week for 2 weeks, or until 2 consecutive cultures are negative, if that occurs sooner. If your doctor feels it is necessary, you may have a repeat chest x-ray.

If at any time you develop signs of pneumonia, you will be removed from the study and will be treated with the standard schedule of ribavirin by continuous inhalation and/or other therapy for 18 hours a day. Also, if you develop any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.

This is an investigational study. Ribavirin is FDA approved and is commercially available. However, the method of administration of ribavirin is investigational. Up to 50 patients will participate in this study. All will be enrolled at M. D. Anderson.

Intermittent Use of Aerosolized Ribavirin for Treatment of RSV

A Randomized Study Evaluating Two Different Schedules of Aerosolized Ribavirin For Treatment of RSV Upper Respiratory Infections in Patients With Hematological Malignancies

Treatment failure defined as progression to pneumonia within 7 days of initial treatment with aerosolized ribavirin. Patients considered as a failure or to have an unfavorable response if there develop signs and symptoms of pneumonia during therapy either evidenced by chest-xray or clinically, meaning they did reach the primary endpoint.

ICN Pharmaceuticals

Aerosolized Ribavirin 6 gm over 18 hours every 24 hours

Standard Schedule - Ribavarin

Aerosolized Ribavirin 6 gm over 3 hours every 8 hours

Modified Schedule - Ribavarin

Age, Categorical

Age Continuous

The interpretation of our data is limited by our study's open-label design, which may bias assessments of tolerability or toxicity but would be less likely to bias assessments of therapeutic endpoints.

Roy F Chemaly, MD/MPH, MBA /Associate Professor

The analysis was carried out per protocol. All patients enrolled were included in the final analysis except one patient who was a screen failure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Respiratory Syncytial Virus - RSV Protocol	NCT01502072	Bone Marrow Tra... Infection in Ma... Respiratory Syn... Respiratory Syn... Cancer Acute Leukemia	Ribavirin Ribavirin	18 Years -	M.D. Anderson Cancer Center
Intermittent Use of Aerosolized Ribavirin for Treatment of RSV	NCT00500578	Hematological M...	Ribavirin Ribavirin	5 Years -	M.D. Anderson Cancer Center
Respiratory Syncytial Virus - RSV Protocol	NCT01502072	Bone Marrow Tra... Infection in Ma... Respiratory Syn... Respiratory Syn... Cancer Acute Leukemia	Ribavirin Ribavirin	18 Years -	M.D. Anderson Cancer Center
Respiratory Syncytial Virus - RSV Protocol	NCT01502072	Bone Marrow Tra... Infection in Ma... Respiratory Syn... Respiratory Syn... Cancer Acute Leukemia	Ribavirin Ribavirin	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for respiratory syncytial virus