Evaluation of two new biologicals (NHS-IL12-IL2 and NHS-IL12 fusion
proteins) in dogs with melanoma.
Heather Wilson, DVM, DACVIM (Oncology)
Clinic Phone: 979-845-2351
Inclusion Criteria and General Background Information:
dog must have a confirmed diagnosis of melanoma and several tests
to ensure his/her general health and to assess how advanced the
disease is prior to treatment. The tumor will be biopsied prior to
therapy. Tumors must be of a certain size (2-8 cm in the longest
diameter) and your dog must have no other significant health
problems. This study also includes dogs with only a single site as
well as dogs with metastatic (spread of the tumor to other
with significant concurrent disease are excluded from this study.
Dogs cannot be receiving concurrent chemotherapy (including
corticosteroids) or radiation therapy. Dogs must be off of all such
therapy for 3 weeks prior to study enrollment. NSAID (nonsteroidal
anti-inflammatory drug) use is allowable if patient has been
receiving > 3 weeks. No dogs under 15 kg (<33 lbs) will be
allowed in this study.
to entry into this study, your dog must have a confirmed diagnosis
of melanoma and staging tests to ensure his/her general health and
to assess how advanced the disease is. The tumor will need to be
biopsied before therapy for this purpose. After the first two days
of NHS-IL-12-IL2 or NHS-IL12 your dog will need to return weekly to
the hospital for evaluation, tumor biopsies (three in total), and
serial blood collections for a total of 4 weeks. At the end of
twenty-eight (28) days your dog's response will be evaluated. Dogs
that have had a positive response can remain on the study and
receive a second cycle of the drug. If there is any sign that your
dog's disease is progressing, he/she will be taken off study. All
visits are required for participation in the study and the support
it provides. Interactions between these drugs and other drugs are
unknown; therefore it is important to tell your veterinarian about
any medications (and supplements) your dog is currently taking. It
is strongly encouraged to eliminate all unnecessary medications.
This should be discussed with your oncologist if you have any
costs associated with this study will be provided as part of your
participation. In the event any complications arise during the
twenty-eight (28) day study period (time period between drug
administration and assessment), their management will be covered by
study funds up to $2000/dog/event. This would include any
unanticipated hospitalizations. However, all costs exceeding
$2000/dog/event are your responsibility.
This trial is currently open.