Clinical Trials and Research Projects  
Vet Clinical Trials
VIN.com


Vet Clinical Trials

Search


Browse by category




Powered By VIN

 

Category: Dogs

RMUW-19 Trial (Study Closed)
September 29, 2009 (published)
Robert Rosenthal
Veterinary Information Network
You do not have permission to view this document: [5942450]!

Study Start Date: 09/01/2009
Study End Date: 08/31/2013

PLEASE NOTE: Due to the untimely death of Dr Bob Rosenthal in May 2012, this study is no longer recruiting cases.

The RMUW-19 trial was inspired by results of the recent VIN lymphoma survey and an interest in seeing how a protocol long-used by an oncologist in specialty practice would  work when administered by general practitioners who are comfortable with handling chemotherapeutic agents in their practices. The survey and the protocol were discussed at Sunday Night Rounds on August 16, 2009, when the trial was announced.

RMUW-19 is an abbreviation for “Rosenthal-Modified University Wisonsin 19 week” protocol (previously referred to as SP-19 protocol).  RMUW-19 is a 19-week/16-treatment sequential combination chemotherapy protocol derived from earlier versions of UWM protocols. The history of that early work and Dr. Rosenthal’s modifications can be found in greater detail in the transcription of the Rounds. Briefly, RMUW-19 uses no asparaginase in the first week of treatment and substitutes chlorambucil for cyclophosphamide in the second week of the second, third, and fourth four-week cycles. The 25-week version of this protocol resulted in response rate of over 90% and a median first remission of 235 days (unpublished data).  RMUW-19 has resulted in a response rate of about 90% and a median first remission of 231 days (unpublished data).  Both of these compare favorably with the response rate of 100% (77%CR and 23%PR) and median first remission of 174 days published by Hosoya, Kisseberth, Lord, et al. in 2007 in JVIM.

Study Design:
Prospective Longitudinal Case Series

Sample Size:
50 dogs

Inclusion Criteria:

  • Dogs with Stage III or Stage IV (substage a or b) lymphoma newly diagnosed by cytology or histopathology are eligible.
  • The clinician must be confident that the diagnosis is correct.
  • Staging does not absolutely require thoracic radiographs, abdominal ultrasound/FNA cytology, or bone marrow, but those are all encouraged as needed to support the clinician’s staging. Again, the clinician must be confident of the designation. Similarly, B/T-cell designation is not mandatory, but that information is welcomed if available.  Again, the clinician must be confident of the diagnosis (not of the designation)...

Exclusion Criteria:

  • Dogs with tumors other than lymphoma.
  • Dogs with significant concurrent disease that would result in a life expectancy of less than six months.

Study Controls:
None.  This is a case series

Study Endpoint:
Time to first remission, measured from the initiation of therapy

Samples:
Information required at the outset will include the clinician’s name and contact information (phone, email), patient’s name, age, weight, breed, gender, method of diagnosis, and stage. In addition, results of pre-treatment CBC, profile biochemical screen, and UA are required. With each treatment, data entry will be required including CBC results and information about toxicity and any dose adjustments/treatment delays, as well as remission status. After the protocol is completed, rechecks with reports of remission status should be done every four to six weeks. Dr. Rosenthal will be available to discuss questions or problems with individual cases, but it is expected that the participants will be able to manage these cases without undue difficulty.  

Patient Enrollment and Update Sites:
Enroll New Patient
Update Existing Patient
Client Consent Form
RMUW-19 Sequential Combination Chemotherapy Protocol

Costs/Reimbursements
Owners will be responsible for all costs.

 

Full Disclosure information:

  • The study is funded by a grant from the VIN Foundation.
  • The investigator does not have a conflict of interest.
  • The study will be published if results are negative
  • The study will be reported on VIN

Have questions or feedback? Email us