Fallopian Tube CancerPhase 2NCT00652899
Allogeneic Natural Killer Cells in Patients With Recurrent Ovarian Cancer, Fallopian Tube, and Primary Peritoneal Cancer
A Phase 2 study testing Allopurinol, Cyclophosphamide and Fludarabine phosphate in people with Fallopian Tube Cancer and Ovarian Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
RATIONALE: Giving chemotherapy, such as cyclophosphamide and fludarabine, and total-body irradiation before a donor natural killer cell infusion helps stop the growth of tumor cells. It also helps stop the patient's immune system from rejecting the donor's natural killer cells. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
- What is being tested?
- Allopurinol, Cyclophosphamide and Fludarabine phosphate
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Aug 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of recurrent ovarian cancer, fallopian tube, or primary peritoneal cancer who meets the following criteria:
- Measurable disease (≥ 1 cm) per Response Evaluation Criteria for Solid Tumors (RECIST) - patients with bone as their only site of metastatic disease will not be eligible
- Progression on or failure to respond to at least 2 salvage chemotherapy regimens (2 regimens given for disease recurrence) for recurrent/metastatic ovarian, fallopian tube, or primary peritoneal cancer
- If history of brain metastases, stable for at least 3 months after treatment - A brain computed tomography (CT) scan will only be required in subjects with known brain metastases at the time of enrollment or in subjects with new clinical signs or symptoms suggestive of brain metastases.
- Available related HLA-haploidentical natural killer (NK) cell donor (by at least class I serologic typing). If biologic parents or siblings are available, can proceed with work-up of subject prior to return of human leukocyte antigen (HLA) typing results.
- Age 18 years or older
Show all 15Show fewer
- Gynecology Oncology Group (GOG) performance status 0 or 1
- Adequate organ function as determined by the following criteria within 14 days of study enrollment:
- Bone marrow: platelets ≥ 80,000 x 10^9/L and hemoglobin ≥ 9g/dL, unsupported by transfusions; absolute neutrophil count (ANC) ≥ 1000 x 10^9/L, unsupported by granulocyte-colony stimulating factor (G-CSF) or granulocyte macrophage-colony stimulating factor (GM-CSF)
- Renal function: creatinine (Cr) ≤ 2.0 mg/dL
- Liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, alkaline phosphatase < 5 times upper limit of institutional normal
- Cardiac: Left ventricular ejection fraction >40%
- Pulmonary function: > 50% corrected Carbon Monoxide Diffusing Capacity (DLCO) and Forced expiratory volume in one second (FEV1), if presence of pleural effusion due to metastatic disease >40% corrected DLCO and FEV1 acceptable.
- Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to Day 0
- Voluntary written informed consent signed before performance of any study related procedure not part of normal medical care.
Who cannot join
- Pregnant or lactating - The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. All females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
- Active infection - subjects must be afebrile, off antibiotics, and with no uninvestigated radiologic lesions (infiltrates or lesions with negative cultures or biopsies are allowed).
- Human anti-mouse antibody (HAMA) monitoring: All subjects will be questioned about prior exposure to antibody therapy (including OKT3, Rituximab, Trastuzumab, etc). Responses will be recorded and reported to the FDA as part of the annual report. For subjects with no prior antibody therapy exposure, no further action will be taken. For subjects who have received previous antibody therapies 10 ml of serum (red top tube) will be drawn before starting therapy and banked per section 8.1. The presence of HAMA will not exclude a patient from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: MT2007-19R: WCC #53 Allogeneic Natural Killer Cells in Patients With Recurrent Ovarian Cancer, Fallopian Tube, and Primary Peritoneal Cancer
RATIONALE: Giving chemotherapy, such as cyclophosphamide and fludarabine, and total-body irradiation before a donor natural killer cell infusion helps stop the growth of tumor cells. It also helps stop the patient's immune system from rejecting the donor's natural killer cells. Aldesleukin may stimulate the natural killer cells to kill ovarian, fallopian tube, or primary peritoneal cancer cells. Treating the donor natural killer cells with aldesleukin may help the natural killer cells kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving laboratory-treated donor natural killer cells together with aldesleukin works when given after cyclophosphamide, fludarabine, and total-body irradiation in treating patients with recurrent and/or metastatic ovarian, fallopian tube, or primary peritoneal cancer.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate the in vivo expansion of an infused allogeneic natural killer (NK) cell product following a preparative regimen comprising cyclophosphamide, fludarabine phosphate, and total-body irradiation in treating patients with recurrent and/or metastatic ovarian, fallopian tube, or primary peritoneal cancer.
Secondary
- To characterize the quantitative and qualitative toxicities of this treatment regimen.
- To estimate disease response (complete or partial response) or clinical benefit (stable disease for > 6 months) as measured by Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
- To estimate time to progression and overall survival.
- To estimate the association between clinical response and donor/recipient KIR ligand matching status.
Tertiary
- To evaluate immune activation of the in vivo expanded haploidentical allogeneic NK cells and its effect on the immune system.
OUTLINE:
- Preparative regimen: Patients receive fludarabine phosphate IV on days 6 to 2 preceding natural killer (NK) cell infusion and cyclophosphamide IV on days 5 and 4 preceding NK cell infusion. Patients also undergo total-body irradiation on day 1 preceding NK cell infusion.
- Allogeneic natural killer (NK) cell administration and aldesleukin: Patients receive aldesleukin-activated haploidentical allogeneic NK cells intravenously (IV) on day 0. Beginning 4-6 hours after allogeneic NK cell infusion, patients receive aldesleukin subcutaneously (SC) 3 times a week for 6 doses.
Patients achieving any initial response (complete or partial response) or a clinical benefit (stable disease for > 6 months) who progress after 6 months may receive 1 re-treatment course as above.
Blood samples are collected at baseline, on days 0, 7, 14, and 28, and then at 2 and 3 months post NK cell infusion for cytokine measurements, immunophenotyping, functional analyses, and testing for persistence of donor cells.
After completion of study treatment, patients are followed periodically for at least 1 year.
- Being tested
- Allopurinol, Cyclophosphamide, Fludarabine phosphate, total-body irradiation, Allogeneic natural killer cells
- Keywords
- recurrent ovarian epithelial cancer, recurrent ovarian germ cell tumor, stage IV ovarian epithelial cancer, stage IV ovarian germ cell tumor, fallopian tube cancer, peritoneal cavity cancer
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolBiological
Also called Zyloprim
All patients are to receive allopurinol 300 mg PO daily (unless known allergy) before beginning chemotherapy and continuing through day 14 post natural killer cell infusion.
CyclophosphamideDrug
Also called Cytoxan
60 mg/m^2 on Days 4 and 5 preceding natural killer cell infusion.
Also called Fludarabine
25 mg/m^2 on Days 6 through 2 preceding natural killer cell infusion.
total-body irradiationRadiation
Also called TBI
200 cGy Day 1 preceding natural killer cell infusion.
Allogeneic natural killer cellsBiological
Also called related donor haploidentical allogenic cell infusion
Given day 0 - dose of 1.5-8.0 * 10^7/kg
AldesleukinBiological
Also called IL-2, Interleukin-2
10 MU 3 times/week for a total of 6 doses beginning Day 0
| Study group | Role | What they receive |
|---|---|---|
| Total Body Irradiation | Experimental | This group includes patients that received all chemotherapy, infusion of natural killer (NK) cells and total body irradiation per protocol.
1. Allopurinol 300 mg by mouth daily (unless known allergy) before beginning chemotherapy and continuing through day 14 post NK cell infusion. 2. Cyclophosphamide 60 mg/m^2 on Days 4 and 5 preceding NK cell infusion. 3. Fludarabine phosphate 25 mg/m^2 on Days 6 through 2 preceding NK cell infusion. 4. Radiation: total-body irradiation 200 cGy Day 1 preceding NK cell infusion. 5. Allogeneic natural killer cells- Given day 0 - dose of 1.5-8.0 * 10^7/kg. 6. Aldesleukin 10 million units 3 times/week for a total of 6 doses beginning Day 0. Receives: Biological: Allopurinol; Drug: Cyclophosphamide; Drug: Fludarabine phosphate; Radiation: total-body irradiation; Biological: Allogeneic natural killer cells; Biological: Aldesleukin |
| No Total Body Irradiation | Experimental | This group includes patients that received chemotherapy and infusion of natural killer cells, but did not receive total body irradiation.
1. Allopurinol 300 mg by mouth daily (unless known allergy) before beginning chemotherapy and continuing through day 14 post NK cell infusion. 2. Cyclophosphamide 60 mg/m^2 on Days 4 and 5 preceding NK cell infusion. 3. Fludarabine phosphate 25 mg/m^2 on Days 6 through 2 preceding NK cell infusion. 4. Allogeneic natural killer cells- Given day 0 - dose of 1.5-8.0 * 10^7/kg. 5. Aldesleukin 10 million units 3 times/week for a total of 6 doses beginning Day 0. Receives: Biological: Allopurinol; Drug: Cyclophosphamide; Drug: Fludarabine phosphate; Biological: Allogeneic natural killer cells; Biological: Aldesleukin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With In Vivo Expansion of Infused Allogeneic Natural Killer (NK) Cell Product
Detection of an absolute donor derived cell count of > or = 100 cells/mL after NK cell infusion.
Measured: Day 12-14
Secondary outcomes (3)
Number of Patients Per Disease Response
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.
Measured: 1 Month After Natural Killer Cell Infusion (Day 30)
Median Number of Days to Progression
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.
Measured: From date of first treatment to disease progression
Median Overall Survival Number of Days Patients Alive After Treatment
Median number of days patients alive from date of treatment to date of death or date of last follow-up if censored.
Measured: From first date on-study (treatment) to date of death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: Withdrawn due to toxicity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fallopian Tube CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa A. Geller, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652899
- Sponsor's protocol ID
- 2007LS138
- Other IDs
- UMN-MT2007-19R, UMN-WCC-53, UMN-0712M23462
- Status last verified
- Dec 2017
- First submitted
- 3 Apr 2008
- Last updated
- 28 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MT2007-19R: WCC #53 Allogeneic Natural Killer Cells in Patients With Recurrent Ovarian Cancer, Fallopian Tube, and Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT00652899
- Acronym / sponsor ID
- 2007LS138
- Keywords
- recurrent ovarian epithelial cancer, recurrent ovarian germ cell tumor, stage IV ovarian epithelial cancer, stage IV ovarian germ cell tumor, fallopian tube cancer, peritoneal cavity cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Withdrawn due to toxicity
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 4 Apr 2008 (estimated)
- Results
- Posted 15 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Giving chemotherapy, such as cyclophosphamide and fludarabine, and total-body irradiation before a donor natural killer cell infusion helps stop the growth of tumor cells. It also helps stop the patient's immune system from rejecting the donor's natural killer cells. Aldesleukin may stimulate the natural killer cells to kill ovarian, fallopian tube, or primary peritoneal cancer cells. Treating the donor natural killer cells with aldesleukin may help the natural killer cells kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving laboratory-treated donor natural killer cells together with aldesleukin works when given after cyclophosphamide, fludarabine, and total-body irradiation in treating patients with recurrent and/or metastatic ovarian, fallopian tube, or primary peritoneal cancer.
Detailed description
OBJECTIVES:
Primary
- To evaluate the in vivo expansion of an infused allogeneic natural killer (NK) cell product following a preparative regimen comprising cyclophosphamide, fludarabine phosphate, and total-body irradiation in treating patients with recurrent and/or metastatic ovarian, fallopian tube, or primary peritoneal cancer.
Secondary
- To characterize the quantitative and qualitative toxicities of this treatment regimen.
- To estimate disease response (complete or partial response) or clinical benefit (stable disease for > 6 months) as measured by Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
- To estimate time to progression and overall survival.
- To estimate the association between clinical response and donor/recipient KIR ligand matching status.
Tertiary
- To evaluate immune activation of the in vivo expanded haploidentical allogeneic NK cells and its effect on the immune system.
OUTLINE:
- Preparative regimen: Patients receive fludarabine phosphate IV on days 6 to 2 preceding natural killer (NK) cell infusion and cyclophosphamide IV on days 5 and 4 preceding NK cell infusion. Patients also undergo total-body irradiation on day 1 preceding NK cell infusion.
- Allogeneic natural killer (NK) cell administration and aldesleukin: Patients receive aldesleukin-activated haploidentical allogeneic NK cells intravenously (IV) on day 0. Beginning 4-6 hours after allogeneic NK cell infusion, patients receive aldesleukin subcutaneously (SC) 3 times a week for 6 doses.
Patients achieving any initial response (complete or partial response) or a clinical benefit (stable disease for > 6 months) who progress after 6 months may receive 1 re-treatment course as above.
Blood samples are collected at baseline, on days 0, 7, 14, and 28, and then at 2 and 3 months post NK cell infusion for cytokine measurements, immunophenotyping, functional analyses, and testing for persistence of donor cells.
After completion of study treatment, patients are followed periodically for at least 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Body Irradiation | Experimental | Biological: Allopurinol, Drug: Cyclophosphamide, Drug: Fludarabine phosphate, Radiation: total-body irradiation, Biological: Allogeneic natural killer cells, Biological: AldesleukinThis group includes patients that received all chemotherapy, infusion of natural killer (NK) cells and total body irradiation per protocol. 1. Allopurinol 300 mg by mouth daily (unless known allergy) before beginning chemotherapy and continuing through day 14 post NK cell infusion. 2. Cyclophosphamide 60 mg/m^2 on Days 4 and 5 preceding NK cell infusion. 3. Fludarabine phosphate 25 mg/m^2 on Days 6 through 2 preceding NK cell infusion. 4. Radiation: total-body irradiation 200 cGy Day 1 preceding NK cell infusion. 5. Allogeneic natural killer cells- Given day 0 - dose of 1.5-8.0 * 10^7/kg. 6. Aldesleukin 10 million units 3 times/week for a total of 6 doses beginning Day 0. |
| No Total Body Irradiation | Experimental | Biological: Allopurinol, Drug: Cyclophosphamide, Drug: Fludarabine phosphate, Biological: Allogeneic natural killer cells, Biological: AldesleukinThis group includes patients that received chemotherapy and infusion of natural killer cells, but did not receive total body irradiation. 1. Allopurinol 300 mg by mouth daily (unless known allergy) before beginning chemotherapy and continuing through day 14 post NK cell infusion. 2. Cyclophosphamide 60 mg/m^2 on Days 4 and 5 preceding NK cell infusion. 3. Fludarabine phosphate 25 mg/m^2 on Days 6 through 2 preceding NK cell infusion. 4. Allogeneic natural killer cells- Given day 0 - dose of 1.5-8.0 * 10^7/kg. 5. Aldesleukin 10 million units 3 times/week for a total of 6 doses beginning Day 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Diagnosis of recurrent ovarian cancer, fallopian tube, or primary peritoneal cancer who meets the following criteria:
- Measurable disease (≥ 1 cm) per Response Evaluation Criteria for Solid Tumors (RECIST) - patients with bone as their only site of metastatic disease will not be eligible
- Progression on or failure to respond to at least 2 salvage chemotherapy regimens (2 regimens given for disease recurrence) for recurrent/metastatic ovarian, fallopian tube, or primary peritoneal cancer
- If history of brain metastases, stable for at least 3 months after treatment - A brain computed tomography (CT) scan will only be required in subjects with known brain metastases at the time of enrollment or in subjects with new clinical signs or symptoms suggestive of brain metastases.
- Available related HLA-haploidentical natural killer (NK) cell donor (by at least class I serologic typing). If biologic parents or siblings are available, can proceed with work-up of subject prior to return of human leukocyte antigen (HLA) typing results.
Key exclusion criteria (3 listed)
- Pregnant or lactating - The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. All females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
- Active infection - subjects must be afebrile, off antibiotics, and with no uninvestigated radiologic lesions (infiltrates or lesions with negative cultures or biopsies are allowed).
- Human anti-mouse antibody (HAMA) monitoring: All subjects will be questioned about prior exposure to antibody therapy (including OKT3, Rituximab, Trastuzumab, etc). Responses will be recorded and reported to the FDA as part of the annual report. For subjects with no prior antibody therapy exposure, no further action will be taken. For subjects who have received previous antibody therapies 10 ml of serum (red top tube) will be drawn before starting therapy and banked per section 8.1. The presence of HAMA will not exclude a patient from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AllopurinolAlso: ZyloprimAll patients are to receive allopurinol 300 mg PO daily (unless known allergy) before beginning chemotherapy and continuing through day 14 post natural killer cell infusion. | Biological | No Total Body Irradiation, Total Body Irradiation |
| CyclophosphamideAlso: Cytoxan60 mg/m^2 on Days 4 and 5 preceding natural killer cell infusion. | Drug | No Total Body Irradiation, Total Body Irradiation |
| Fludarabine phosphateAlso: Fludarabine25 mg/m^2 on Days 6 through 2 preceding natural killer cell infusion. | Drug | No Total Body Irradiation, Total Body Irradiation |
| total-body irradiationAlso: TBI200 cGy Day 1 preceding natural killer cell infusion. | Radiation | Total Body Irradiation |
| Allogeneic natural killer cellsAlso: related donor haploidentical allogenic cell infusionGiven day 0 - dose of 1.5-8.0 * 10^7/kg | Biological | No Total Body Irradiation, Total Body Irradiation |
| AldesleukinAlso: IL-2, Interleukin-210 MU 3 times/week for a total of 6 doses beginning Day 0 | Biological | No Total Body Irradiation, Total Body Irradiation |
Primary outcome
Number of Patients With In Vivo Expansion of Infused Allogeneic Natural Killer (NK) Cell Product
Time frame: Day 12-14
Detection of an absolute donor derived cell count of > or = 100 cells/mL after NK cell infusion.
3 secondary outcomes
Number of Patients Per Disease Response
Time frame: 1 Month After Natural Killer Cell Infusion (Day 30)
Median Number of Days to Progression
Time frame: From date of first treatment to disease progression
Median Overall Survival Number of Days Patients Alive After Treatment
Time frame: From first date on-study (treatment) to date of death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa A. Geller, MD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allopurinol, Cyclophosphamide and Fludarabine phosphate in people with Fallopian Tube Cancer and Ovarian Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With In Vivo Expansion of Infused Allogeneic Natural Killer (NK) Cell Product (time frame: Day 12-14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2017.