TriangleNCT00652899 · STUDY IN CONTEXT
Allogeneic Natural Killer Cells in Patients With Recurrent Ovarian Cancer, Fallopian Tube, and Primary Peritoneal Cancer
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Detection of an absolute donor derived cell count of \> or = 100 cells/mL after NK cell infusion.
Response Evaluation Criteria in Solid Tumors (RECIST) criteria: Complete Response (CR)-Disappearance of all target lesions (TL); Partial Response (PR)-\< or = 30% decrease in the sum of the longest diameter (LD) of TL, reference baseline sum LD; Stable Disease (SD)-Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference the smallest sum LD since the treatment started; Progressive Disease (PD)- \< or = 20% increase in the sum of the LD of TL, reference the smallest sum LD recorded since treatment started or appearance of \< or = 1 new lesion.
Median number of days from first date of treatment to date of disease progression (appearance of new metastatic lesions or objective tumor progression). Defined by computated tomography (CT) imaging based on Response Evaluation Criteria In Solid Tumors (RECIST): Progressive Disease (PD) \> or = 20% increase in sum of all target or any new lesions.
Median number of days patients alive from date of treatment to date of death or date of last follow-up if censored.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT00652899
- trial label
- Allogeneic Natural Killer Cells in Patients With Recurrent Ovarian Cancer, Fallopian Tube, and Primary Peritoneal Cancer
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 4
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT00652899
- outcome key
- om-0000
- source section id
- NCT00652899-om-0000
- source outcome index
- 0
- endpoint
- Number of Patients With In Vivo Expansion of Infused Allogeneic Natural Killer (NK) Cell Product
- endpoint definition
- Detection of an absolute donor derived cell count of \> or = 100 cells/mL after NK cell infusion.
- time origin
- Day 12-14
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT00652899
- outcome key
- om-0001
- source section id
- NCT00652899-om-0001
- source outcome index
- 1
- endpoint
- Number of Patients Per Disease Response
- endpoint definition
- Response Evaluation Criteria in Solid Tumors (RECIST) criteria: Complete Response (CR)-Disappearance of all target lesions (TL); Partial Response (PR)-\< or = 30% decrease in the sum of the longest diameter (LD) of TL, reference baseline sum LD; Stable Disease (SD)-Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference the smallest sum LD since the treatment started; Progressive Disease (PD)- \< or = 20% increase in the sum of the LD of TL, reference the smallest sum LD recorded since treatment started or appearance of \< or = 1 new lesion.
- time origin
- 1 Month After Natural Killer Cell Infusion (Day 30)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Includes 12 patients that completed treatment per protocol criteria.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT00652899
- outcome key
- om-0002
- source section id
- NCT00652899-om-0002
- source outcome index
- 2
- endpoint
- Median Number of Days to Progression
- endpoint definition
- Median number of days from first date of treatment to date of disease progression (appearance of new metastatic lesions or objective tumor progression). Defined by computated tomography (CT) imaging based on Response Evaluation Criteria In Solid Tumors (RECIST): Progressive Disease (PD) \> or = 20% increase in sum of all target or any new lesions.
- time origin
- From date of first treatment to disease progression
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT00652899
- outcome key
- om-0003
- source section id
- NCT00652899-om-0003
- source outcome index
- 3
- endpoint
- Median Overall Survival Number of Days Patients Alive After Treatment
- endpoint definition
- Median number of days patients alive from date of treatment to date of death or date of last follow-up if censored.
- time origin
- From first date on-study (treatment) to date of death
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT00652899
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Ovarian/Fallopian Tube/Peritoneal Cancer Patients
- regimen
- This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m\^2 and fludarabine 25 mg/m\^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 \* 10\^7 kg) and/or total body irradiation per protocol (200 Gy on Day 1 preceding natural killer cell infusion).
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00652899-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT00652899
- outcome key
- om-0001
- arm key
- OG000
- arm label
- No Total Body Irradiation
- regimen
- This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m\^2 and fludarabine 25 mg/m\^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 \* 10\^7 kg) and no total body irradiation.
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00652899-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT00652899
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Total Body Irradiation
- regimen
- This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m\^2 and fludarabine 25 mg/m\^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 \* 10\^7 kg) and total body irradiation (200 Gy on Day 1 preceding natural killer cell infusion).
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00652899-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT00652899
- outcome key
- om-0002
- arm key
- OG000
- arm label
- No Total Body Irradiation
- regimen
- This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m\^2 and fludarabine 25 mg/m\^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 \* 10\^7 kg) and no total body irradiation.
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00652899-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT00652899
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Total Body Irradiation
- regimen
- This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m\^2 and fludarabine 25 mg/m\^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 \* 10\^7 kg) and total body irradiation (200 Gy on Day 1 preceding natural killer cell infusion).
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00652899-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT00652899
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Total Body Irradiation
- regimen
- This group includes patients that received chemotherapy, infusion of natural killer cells and total body irradiation per protocol.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00652899-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT00652899
- outcome key
- om-0003
- arm key
- OG001
- arm label
- No Total Body Irradiation
- regimen
- This group includes patients that received chemotherapy, infusion of natural killer cells and no total body irradiation per protocol.
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00652899-om-0003#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT00652899
- harm key
- EG000
- source section id
- NCT00652899-ae
- event group key
- EG000
- event group label
- All Patients Enrolled
- serious affected
- 9
- serious at risk
- 14
- other affected
- 13
- other at risk
- 14
- frequency threshold
- 5
- collection period
- Serious adverse events were monitored through the follow-up period; death was followed for up to 2 years after Day 1 treatment.
- event definition
- 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice