Allogeneic Natural Killer Cells in Patients With Recurrent Ovarian Cancer, Fallopian Tube, and Primary Peritoneal Cancer
This study has been terminated.
(Withdrawn due to toxicity)
Sponsor:
Masonic Cancer Center, University of Minnesota
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00652899
First received: April 3, 2008
Last updated: November 6, 2012
Last verified: November 2012
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Results First Received: August 20, 2010
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Conditions: |
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
| Interventions: |
Biological: Allopurinol Drug: Cyclophosphamide Drug: Fludarabine phosphate Radiation: total-body irradiation Biological: Allogeneic natural killer cells Biological: Aldesleukin |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Two patients did not receive all of study treatment per protocol. |
Reporting Groups
| Description | |
|---|---|
| All Patients Enrolled | This group includes all patients consented to participate in this study. |
Participant Flow: Overall Study
| All Patients Enrolled | |
|---|---|
| STARTED | 14 |
| COMPLETED | 12 |
| NOT COMPLETED | 2 |
| Death | 1 |
| Treating physician decision | 1 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| All Patients Enrolled | This group includes all patients consented to participate in this study. |
Baseline Measures
| All Patients Enrolled | |
|---|---|
|
Number of Participants
[units: participants] |
14 |
|
Age
[units: participants] |
|
| <=18 years | 0 |
| Between 18 and 65 years | 14 |
| >=65 years | 0 |
|
Age
[units: years] Mean ± Standard Deviation |
55 ± 5.19 |
|
Gender
[units: participants] |
|
| Female | 14 |
| Male | 0 |
|
Region of Enrollment
[units: participants] |
|
| United States | 14 |
Outcome Measures
| 1. Primary: | Number of Patients With In Vivo Expansion of Infused Allogeneic Natural Killer (NK) Cell Product [ Time Frame: Day 12-14 ] |
| 2. Secondary: | Number of Patients Per Disease Response [ Time Frame: 1 Month After Natural Killer Cell Infusion (Day 30) ] |
| 3. Secondary: | Median Number of Days to Progression [ Time Frame: From date of first treatment to disease progression ] |
| 4. Secondary: | Median Overall Survival Number of Days Patients Alive After Treatment [ Time Frame: From first date on-study (treatment) to date of death ] |
Serious Adverse Events Other Adverse Events
| Time Frame | Serious adverse events were monitored through the follow-up period; death was followed for up to 2 years after Day 1 treatment. |
|---|---|
| Additional Description | Adverse event collection for the purposes of this study focused on targeted adverse events and unexpected adverse events at specific time points in relation to the NK cell infusion and post infusion IL-2 injections. |
Frequency Threshold
| Threshold above which other adverse events are reported | 5% |
|---|
Reporting Groups
| Description | |
|---|---|
| All Patients Enrolled | This group includes all patients consented to participate in this study. |
Other Adverse Events
| All Patients Enrolled | |
|---|---|
| Total, other (not including serious) adverse events | |
| # participants affected / at risk | 13/14 |
| Blood and lymphatic system disorders | |
| Edema † 1 | |
| # participants affected / at risk | 6/14 (42.86%) |
| # events | 29 |
| Positive blood culture with fever † 1 | |
| # participants affected / at risk | 2/14 (14.29%) |
| # events | 5 |
| Hemolysis † 1 | |
| # participants affected / at risk | 1/14 (7.14%) |
| # events | 1 |
| Cardiac disorders | |
| Hypertension † 1 | |
| # participants affected / at risk | 1/14 (7.14%) |
| # events | 8 |
| Gastrointestinal disorders | |
| Vomiting † 1 | |
| # participants affected / at risk | 11/14 (78.57%) |
| # events | 30 |
| Nausea † 1 | |
| # participants affected / at risk | 12/14 (85.71%) |
| # events | 80 |
| General disorders | |
| Fever † 1 | |
| # participants affected / at risk | 12/14 (85.71%) |
| # events | 42 |
| Chills † 1 | |
| # participants affected / at risk | 12/14 (85.71%) |
| # events | 44 |
| Fatigue † 1 | |
| # participants affected / at risk | 13/14 (92.86%) |
| # events | 115 |
| Musculoskeletal and connective tissue disorders | |
| Myalgia † 1 | |
| # participants affected / at risk | 9/14 (64.29%) |
| # events | 28 |
| Respiratory, thoracic and mediastinal disorders | |
| Dyspnea † 1 | |
| # participants affected / at risk | 6/14 (42.86%) |
| # events | 23 |
| Pneumonia † 1 | |
| # participants affected / at risk | 3/14 (21.43%) |
| # events | 17 |
| Cough † 1 | |
| # participants affected / at risk | 5/14 (35.71%) |
| # events | 18 |
| Skin and subcutaneous tissue disorders | |
| Injection Site Reaction † 1 | |
| # participants affected / at risk | 11/14 (78.57%) |
| # events | 58 |
| Rash † 1 | |
| # participants affected / at risk | 11/14 (78.57%) |
| # events | 45 |
| Sweats † 1 | |
| # participants affected / at risk | 10/14 (71.43%) |
| # events | 27 |
| † | Events were collected by systematic assessment |
|---|---|
| 1 | Term from vocabulary, CTCAE (3.0) |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| All Principal Investigators ARE employed by the organization sponsoring the study. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
|
Endpoint for association of clinical benefit response with donor/recipient KIR ligand matching status is not evaluable due to 0 complete responders. Correlative laboratory objectives are irrelevant due to ineffectiveness of study regimen. |
Results Point of Contact:
Name/Title: Melissa Geller, M.D.
Organization: University of Minnesota, Dept. Ob/Gyn
phone: 612-626-3111
e-mail: gelle005@umn.edu
Organization: University of Minnesota, Dept. Ob/Gyn
phone: 612-626-3111
e-mail: gelle005@umn.edu
No publications provided
| Responsible Party: | Masonic Cancer Center, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00652899 History of Changes |
| Other Study ID Numbers: | 2007LS138, UMN-MT2007-19R, UMN-WCC-53, UMN-0712M23462 |
| Study First Received: | April 3, 2008 |
| Results First Received: | August 20, 2010 |
| Last Updated: | November 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |