Ovarian Cancer Clinical Trial
Official title:
MT2007-19R: WCC #53 Allogeneic Natural Killer Cells in Patients With Recurrent Ovarian Cancer, Fallopian Tube, and Primary Peritoneal Cancer
Verified date | December 2017 |
Source | Masonic Cancer Center, University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 14 |
Est. completion date | August 2009 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Masonic Cancer Center, University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Day 12-14 | |
Secondary | 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. | 1 Month After Natural Killer Cell Infusion (Day 30) | |
Secondary | 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. | From date of first treatment to disease progression | |
Secondary | 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. | From first date on-study (treatment) to date of death |
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