Researchers at the University of Nebraska Medical Center are participating
in a nationwide clinical trial to evaluate the safety and effectiveness
of combining standard initial chemotherapy with IM862, a compound that
appears to have cancer fighting properties. Pre-clinical research suggests
that IM862 stimulates the bodys immune system and inhibits the development
of blood vessels needed by tumors to grow and spread.
The University of Washington and Fred Hutchinson Cancer Research Centers
Puget Sound Oncology Consortium will lead the multi-center trial which
will involve 180 women with stage III ovarian cancer at 15 medical centers,
in addition to Omaha. Study sites are also located in Seattle, St. Louis,
Chapel Hill, N.C., Minneapolis, Los Angeles, Buffalo, N.Y., Madison, Wis.,
Cleveland, Washington, D.C. and Palo Alto, Calif.
About 27,000 new cases of ovarian cancer are detected each year in this
country and some 15,000 women die annually from the disease. Because no
reliable means of early detection exists, most cases are not diagnosed
before they reach an advanced stage. The majority of women with stage III
ovarian cancer initially achieve complete remission with surgery and standard
chemotherapy. However, many patients relapse with time.
It may provide more therapeutic benefits than other compounds. This
is an exciting protocol because of its unique method of delivery, via nose
drops, which patients can easily learn, said Kelly Molpus, M.D., director
of the UNMC Division of Gynecologic Oncology. The side effects have been
minimal, and therefore does not add significantly to the potential side
effects of standard chemotherapy.
To date, IM862 has been tested in clinical trials involving over 400
cancer patients and has demonstrated a favorable safety profile with generally
mild side effects, said Pamela Paley, M.D., gynecological oncologist at
the University of Washington and one of the principal investigators of
the study.
IM862 may reduce blood vessels that feed tumor cells, as well as increase
the ability of the patients own immune system to kill the cancer, said
Dr. Paley. Our hope is that the combination of IM862 and chemotherapy
will result in a larger number of women with ovarian cancer achieving long
term remission from their disease with little or no additional toxicity.
Women eligible for the study must be 18 years or older and newly diagnosed
with stage III ovarian cancer and have undergone optimal surgery for removal
of their tumor and not received prior treatment for their cancer. Patients
will be randomized to one of three arms of the study, each with a different
dose of IM862, while undergoing conventional treatment of six cycles of
chemotherapy.
Following combined treatment of chemotherapy and IM862, second look
surgery will be performed to assess presence of disease. Patients with
no evidence of disease, or with only microscopically detectable residual
disease, will be treated with IM862 for an additional 24 weeks. The trial
is double-blinded so neither patient nor physician will know which dose
of study drug the patient is receiving.
The studys primary objective is to determine the safety of IM862 when
it is given with chemotherapy as well as if the addition of IM862 increases
the percentage of patients with no evidence of disease at second look surgery.
Historically, about half of patients show evidence of disease at that time.
Secondary objectives include evaluation of occurrence of infection or other
complications, length of remission and the ability of IM862 to decrease
tumor blood supply and stimulate the immune system.
IM862, developed by Cytran, Inc. of Kirkland, Wash., is a synthesized
version of a naturally occurring small compound.
For more information on the study, contact Dr. Molpus at (402) 559-5068
or Cytran at (877) 449-4692 or visit the Cytran web site at www.cytran.com.