A Phase II Study of Chemoimmunotherapy for Patients With Potentially Platinum Sensitive Müllerian (Epithelial Ovarian, Peritoneal, or Fallopian Tube) Carcinomas
Carboplatin is a chemotherapy drug that is used for the treatment of ovarian cancer. GM-CSF
is a protein that is used to increase the production of white blood cells. rIFN-g is a
protein that stimulates cells of the immune system.
Participants will need to have pre-study blood work (about 4 teaspoons) as part of their
evaluation for study entry. In addition, a chest x-ray and CT scan of the abdomen and
pelvis will need to be done before any treatments.
Participants in this study will receive a frequently used dose of carboplatin by vein over 1
hour every 28 days. In addition, GM-CSF will be given for 7 days and rIFN-g will be given
for 2 days before and after chemotherapy. Both drugs will be given as injections under the
skin. They will be repeated with each chemotherapy course that participants receive.
GM-CSF and rIFN-g are being used to try to stimulate the immune system in the belief that
this adds to the effectiveness of the chemotherapy on the tumor. During each course of
chemotherapy treatment, blood samples will be taken in order to evaluate the blood count
response to GM-CSF. Participants will need to remain in the Houston area beginning with the
first injection of GM-CSF and for up to 9 days following the carboplatin infusion for the
QOL forms will be completed at 5 separate time points during the first course of
chemotherapy. Later courses will only have 2 time points for completion of the QOL forms.
The completion of these forms will help researchers to evaluate the effects of the
carboplatin and the 2 proteins on participants and their quality of life.
Participants will receive 3 courses of treatment (each course will include 1 treatment with
carboplatin followed by 2 separate treatment cycles with GM-CSF and rIFN-g) and then be
evaluated for tumor response. If the tumor is responding, 3 additional courses will be
given. If after 6 courses of treatment, the tumor has completely responded and there is no
evidence of the disease, then up to 4 additional courses can be given for completion of
therapy. If the tumor is still responding after 6 courses but has not completely gone away,
then additional courses can be given as long as the tumor is responding before completion
therapy can be considered.
Completion therapy will include carboplatin given every 28 days by vein along with
injections of GM-CSF under the skin before and after the chemotherapy. Injections of rIFN-g
will be given directly into the abdomen through an abdominal catheter if possible. If this
is not possible, then the rIFN-g will be given as injections under the skin. Participants
may choose not to receive the rIFN-g through a catheter during the completion phase and can
continue to receive it under the skin with the chemotherapy. A maximum of 4 additional
courses can be given during this phase of the study.
Participants whose disease gets worse will be taken off the study. Participants who have
intolerable side effect from the study drugs will also be taken off the study treatment.
Participants will have follow up CT scans after every 3 courses of treatment. Following
completion of all treatments, participants will need to return to M. D. Anderson every 3
months for follow-up exams. This will include a physical exam, blood work, and a CT scan.
This is an investigational study. A total of 65 patients will take part in this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients With Response
Per World Health Organization (WHO) Tumor Response: Complete Response (CR), Partial Response (PR) or Progressive Disease (PD). CR defined as disappearance of all target lesions, PR as > = 30% decrease in sum of longest dimensions of target lesions with reference baseline sum longest dimensions and if CA 125 levels declined by >50%, provided target lesion size did not increase by >20% on imaging, and PD as >20% increase in sum of longest dimensions of target lesions taking as references smallest sum of longest dimensions recorded since treatment started, or appearance of 1 or > new lesions.
Follow up CT scans after every 3 courses of treatment and following completion of all treatments.
Ralph Freedman, MD, PhD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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