Epithelial Ovarian Cancer, Extraovarian Peritoneal Cancer, Fallopian Tube Carcinoma
Conditions
Keywords
Epithelial Ovarian Cancer, FIGO (International Fed of Gyn and Ob)Stage III or Stage IV, Extraovarian Peritoneal Cancer, Fallopian Tube Carcinoma Failing
Brief summary
This study tests whether denileukin diftitox will deplete regulatory T cells, boost tumor-specific immunity and treat epithelial ovarian cancer in patients who have failed, or who are ineligible for front line therapy.
Detailed description
This is a non-randomized, single-arm, Phase II trial. Selected patients with advanced-stage epithelial ovarian cancers who have no reasonable chance of cure using standard regimens, or who will not receive such regimens (due to contraindication or intolerance) are eligible. Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
Interventions
DRUGOntak
Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to provide informed consent * Not on Immune modulating drugs * Life expectancy less than 6 months
Exclusion criteria
* Unable to tolerate phlebotomy * Germ cell or stromal cell cancers of the ovaries * Active autoimmune disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Demonstrating Clinical Response | 2 years | Assess the efficacy of Ontak to treat selected advanced-stage ovarian epithelial cancers measured by clinical response rate, disease-free progression, and overall survival. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity | 3 years | Determine any toxicity associated with Ontak treatment in these patients. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ontak Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria. | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Ontak |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 63 years STANDARD_DEVIATION 1 |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
Number of Participants Demonstrating Clinical Response
Assess the efficacy of Ontak to treat selected advanced-stage ovarian epithelial cancers measured by clinical response rate, disease-free progression, and overall survival.
Time frame: 2 years
Population: Measurements performed by RECIST criteria and response reported as a percent. 56 subjects needed to be recruited to the study to determine efficacy. Analysis was on an intent to treat basis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ontak | Number of Participants Demonstrating Clinical Response | 19 participants |
Secondary
Toxicity
Determine any toxicity associated with Ontak treatment in these patients.
Time frame: 3 years
Population: N/A data were not collected