Open Label, Single Arm, Phase I/II Study of CADI-05 in Patients With Advanced Stage III or Stage IV Melanoma
Because there are no highly effective treatment options for patients with advanced,
unresectable melanoma, participation in clinical trials of novel therapies is frequently the
best therapeutic alternative. CADI-05 is a promising agent for two reasons. First,
patients with advanced melanoma frequently have disturbing symptoms such as anorexia with
associated weight loss, fatigue, and chemotherapy-associated side effects such as nausea and
vomiting. CADI-05 not only has a very low side effect profile, but it actually improves
such symptoms. Second, melanomas are generally immunogenic, and sometimes patients mount
significant of immune responses to cause spontaneous regression of tumors. High-dose
interleukin-2, a relatively toxic therapy that stimulates the immune system, causes
long-term regression in stage IV melanoma in a small percentage of patients. In addition,
when combined with adoptive immunotherapy, response rates as high as 50% have been observed.
Therefore, induction of potent antitumor immune responses in melanoma can be a highly
effective therapeutic modality. Because CADI-05 has potent immunostimulatory effects and an
excellent side effect profile, it is a very attractive option for treatment of stage IV
melanoma patients. Preliminary data from ongoing preclinical studies in a murine melanoma
model have shown that CADI-05 has significant biological activity in metastatic melanoma (G.
Robertson, unpublished data).
Although it is possible that CADI-05 as a single agent will have activity in advanced
melanoma, it may also be useful in conjunction with other systemic agents or as an adjuvant
in conjunction with immunotherapy regimens. In addition, previous human trials suggest that
CADI-05 may be helpful in symptom control and improvement of quality of life in patients
with advanced melanoma. In spite of the promising data from a number of preclinical and
clinical studies of this agent, no U.S. studies of the effects of CADI-05 in cancer patients
have been performed. Therefore, the present research study proposes to evaluate the safety
of CADI-05 treatment in advanced melanoma. In addition, preliminary data regarding the
clinical response rate and immune response will be collected.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Recording of any clinical adverse reactions at anytime during the study for assessment of safety.
Paul J Mosca, M.D., Ph.D.
Lehigh Valley Hospital
United States: Food and Drug Administration
|Lehigh Valley Hospital||Allentown, Pennsylvania 18103|