In three combined drugs used in nasopharyngeal carcinoma, the valproic acid and valganciclovir administration will be followed by indication to find the maximum tolerance dose of gemcitabine.

Nasopharyngeal Carcinoma

Gemcitabine will be administrated 600~1250 mg/m^2 intravenously according to the body surface area at day 1 and day 8 in a 28 day-treatment cycle. The treatment cycle of 28 days will be repeated maximum 6 times. The first dose level of gemcitabine will be started at 800 mg/m^2. If no subject suffered the dose limit toxicity, 1000 mg/m^2 and even 1250 mg/m^2 will be started by order. If subjects suffered the dose limit toxicity in 800 mg/m^2, the 600 mg/m^2 will be started.

Gemcitabine

Valproic acid will be administrated orally by the fixed dose 12.5 mg/kg/day according to instructions from day 1 to day 14 in one treatment cycle. The treatment cycle of 28 days will be repeated maximum 6 times.

Valproic acid

Valganciclovir will be administrated orally by the fixed dose 1350 mg/day (creatinine clearance rate ≥ 60 mL/min) or 900 mg/day (creatinine clearance rate ≥ 40 mL/min and < 60 mL/min) from day 9 to day 15 in one treatment cycle. The treatment cycle of 28 days will be repeated maximum 6 times.

Valganciclovir

Chang-Gung Memorial Hospital, Linkou

Study of Cytolytic Viral Activation Therapy (CVAT) for Recurrent/Metastatic Nasopharyngeal Carcinoma

Phase I Study of Cytolytic Viral Activation Therapy (CVAT) for Recurrent/Metastatic Nasopharyngeal Carcinoma

According to Worst Toxicity CTCAE v4.03 Grade and FDA indication of gemcitabine, the dose limiting toxicity (DLT) of this trial was determined in the first treatment cycle and DLTs were defined as ≥1 of the following effects attributable to the study drug and requiring discontinuation or a significant dose reduction in the study drug(s):
≥Grade 4 neutropenia >5 days;
≥Grade 4 thrombopenia lasting ≥7 days;
≥Grade 3 anemia;
≥Grade 3 neutropenic fever with a single temperature of >38.3 degree C or a sustained temperature of ≥ 38 degree C for more than one hour;
any ≥Grade 3 non-hematologic toxicity with exception of nausea and vomiting, alopecia, drug-related fever;
≥Grade 3 serum creatinine;
bone marrow and renal function didn't recover to CTCAE Grade ≤ 1 of baseline at the Day 1 of the 2nd treatment course, the treatment can be postponed less than 2 weeks. DLT was recognized when the delayed duration was more than 2 weeks.

The plasma EB virus DNA load will be check by real-time quantitative polymerase chain reaction (PCR). These data will be collected every months when subjects enter this trial and finish their final treatment cycle one weeks, 3 months, and/or 6 months later. These data will be used to supplementary data for tumor status assessment.

Chang Gung Memorial Hospital

TTY Biopharm

Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT).
Pre-conditioning therapy:
All participants will receive pentostatin 4 mg/m^2 on day -28. Patients may receive additional doses on days -21 & -14 depending on cell counts.
Conditioning:
Patients will receive anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6.
Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4.
Patient will then receive pentostatin at a dose of 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3.
Intravenous Busulfan (2nd dose) will be administered on day (-2) to target a total AUC of 16,000 +/- 1600.
Hematopoietic progenitor cells to be infused at least 36 hours after last dose of Busulfan.
Rituximab: Patients with CD20+ expressing malignancies will be treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines.

Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.
Conditioning:
Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4
Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3
Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines

Conditioning Followed by HCT

Sex: Female, Male

Region of Enrollment

The primary endpoint was achievement of >/= 50% donor chimerism in CD3+ peripheral blood lymphocytes by day +28 (± 7) after allogeneic hematopoietic cell transplantation (allo-HCT).

Incidence of Greater Than or Equal to 50% Donor Chimerism

Hematologic engraftment: defined as time to achieve an absolute neutrophil count (ANC) >/= 500/µl for 3 consecutive days or a platelet count of >/= 20,000//µl without the need for platelet support.

Cumulative Incidence of Hematopoietic Cell Engraftment

Median Percentage of Donor Cells in Study Population (Chimerism).

Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +28

Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +100

The cumulative incidence of NRM after allo-HCT.

Non-relapse Mortality Rate (NRM)

Infections: Incidence of infections (opportunistic and non-opportunistic) following conditioning.

Incidence of Infections

The median time from allo-HCT to the initiation of tacrolimus (TAC) taper.
The median time to onset of acute GVHD (aGVHD). Clinical manifestations of acute GVHD include a classic maculopapular rash; persistent nausea and/or emesis; abdominal cramps with diarrhea; and a rising serum bilirubin concentration.

Time to Incidence of Graft Versus Host Disease (GVHD)

By day +100, the cumulative incidence of GVHD, acute of grades 2-4, and 3-4.
At 2 years, the cumulative incidence of chronic GVHD of any severity according to National Institutes of Health (NIH) consensus criteria. Diagnosis of chronic GVHD requires the presence of at least one diagnostic clinical sign of chronic GVHD or the presence of at least one distinctive manifestation confirmed by pertinent biopsy or other relevant tests in the same or another organ. Furthermore, other possible diagnoses for clinical symptoms must be excluded. No time limit is set for the diagnosis of chronic GVHD.
At 2 years, the cumulative incidence of moderate/severe chronic GVHD.

Incidence of Graft Versus Host Disease (GVHD)

PFS at 2 years post-transplant. PFS, defined as time from day of hematopoietic cell infusion to disease relapse. Relapsed disease: Disease was in complete remission post-transplant but returned (e.g., >5% blast in bone marrow or any peripheral blasts).

Percentage of Participants With Progression Free Survival (PFS)

OS at 2 years post-transplant. OS, defined as time from day of hematopoietic cell infusion to death from any cause.

Percentage of Participants With Overall Survival (OS)

Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.
Conditioning:
Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4
Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3
Intravenous Busulfan (2nd dose) on day (-2) to target a total area under curve (AUC) of 16,000 +/- 1600
Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines

Overall Study

Marcie Riches, MD

Hematologic Malignancies

Pre-conditioning therapy:
All participants will receive pentostatin 4 mg/m^2 on day -28. Patients may receive additional doses on days -21 & -14 depending on cell counts.
Participant will receive pentostatin at a dose of 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3.

Pentostatin

Pre-conditioning therapy:
Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4.
Intravenous Busulfan (2nd dose) will be administered on day (-2) to target a total AUC of 16,000 +/- 1600.

Busulfan

Pre-conditioning therapy:
Patients with CD20+ expressing malignancies will be treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines.

Rituximab

Hematopoietic progenitor cells to be infused at least 36 hours after last dose of Busulfan.

Allogeneic Hematopoietic Cell Transplant

H. Lee Moffitt Cancer Center & Research Institute

Phase II Trial of Pentostatin and Targeted Busulfan

Phase II Trial of Pentostatin and Targeted Busulfan as a Novel Reduced Intensity Regimen for Allogeneic Hematopoietic Stem Cell Transplantation Using Laboratory-Guided (CD4-guided) Immunosuppression.

H. Lee Moffitt Cancer Center and Research Institute

Single Agent Chemotherapy. TSPA or DTC101. 3-Drug Combination Chemotherapy plus Triple Intrathecal Therapy. DM/DNR/VCR; plus TIT. 2-Drug Combination Chemotherapy plus Triple Intrathecal Therapy. ARA-C/ASP; plus TIT. 4-Drug Combination Chemotherapy with Leucovorin Rescue plus Triple Intrathecal Therapy. CTX/MP/MTX/VP-16; with CF; plus TIT. 3-Drug Combination Chemotherapy plus Triple Intrathecal Therapy. DM/DNR/VCR; plus TIT. 6-Drug Combination Chemotherapy with Leucovorin Rescue plus Triple Intrathecal Therapy. ARA-C/ASP/CTX/MP/MTX/VP-16; with CF; plus TIT. Radiotherapy plus 3-Drug Combination Chemotherapy. Craniospinal irradiation using x-rays with energies of 4-6 MV (electrons acceptable for spinal cord irradiation); plus ASP/DM/VCR. 2-Drug Combination Chemotherapy Alternating with 2-Drug Combination Chemotherapy. MP/MTX; alternating with CTX/VCR.

Leukemia

filgrastim

asparaginase

cyclophosphamide

daunorubicin hydrochloride

dexamethasone

etoposide

leucovorin calcium

liposomal cytarabine

mercaptopurine

mesna

methotrexate

therapeutic hydrocortisone

thiotepa

vincristine sulfate

low-LET electron therapy

low-LET photon therapy

University of Alabama Comprehensive Cancer Center

MBCCOP - University of South Alabama

University of Arkansas for Medical Sciences

University of California San Diego Cancer Center

Lucile Packard Children's Hospital at Stanford

University of California Davis Medical Center

Children's Hospital and Health Center

Yale Comprehensive Cancer Center

Walter Reed Army Medical Center

Shands Hospital and Clinics, University of Florida

Sylvester Cancer Center, University of Miami

Miami Children's Hospital

CCOP - Florida Pediatric

Emory University Hospital - Atlanta

Children's Memorial Hospital, Chicago

University of Kansas Medical Center

CCOP - Wichita

Via Christi Regional Medical Center

MBCCOP - LSU Medical Center

Tulane University School of Medicine

CCOP - Ochsner

Marlene & Stewart Greenebaum Cancer Center, University of Maryland

Johns Hopkins Oncology Center

Boston Floating Hospital Infants and Children

Dana-Farber Cancer Institute

University of Massachusetts Memorial Medical Center

Children's Hospital of Michigan

University of Mississippi Medical Center

Cardinal Glennon Children's Hospital

Washington University School of Medicine

CCOP - Northern New Jersey

Hackensack University Medical Center

Roswell Park Cancer Institute

Schneider Children's Hospital

Mount Sinai School of Medicine

University of Rochester Cancer Center

State University of New York Health Sciences Center - Stony Brook

State University of New York - Upstate Medical University

Memorial Mission Hospital

Carolinas Medical Center

Presbyterian Healthcare

Duke Comprehensive Cancer Center

East Carolina University School of Medicine

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Oklahoma Memorial Hospital

CCOP - Columbia River Program

St. Christopher's Hospital for Children

Rhode Island Hospital

Medical University of South Carolina

Children's Hospital of Greenville Hospital System

Saint Jude Children's Research Hospital

Medical City Dallas Hospital

Simmons Cancer Center - Dallas

Baylor College of Medicine

San Antonio Military Pediatric Cancer and Blood Disorders Center

MBCCOP - South Texas Pediatric

University of Texas Health Science Center at San Antonio

Cancer Center, University of Virginia HSC

Naval Medical Center, Portsmouth

Massey Cancer Center

West Virginia University Hospitals

Midwest Children's Cancer Center

Cross Cancer Institute

McMaster Division

Hospital for Sick Children

Montreal Children's Hospital

Hopital Sainte Justine

University of Puerto Rico School of Medicine Medical Sciences Campus

Swiss Pediatric Oncology Group Bern

Clinique de Pediatrie

Radiation Therapy and Chemotherapy in Treating Children With CNS Relapse From Acute Lymphoblastic Leukemia

TREATMENT OF ISOLATED CNS RELAPSE OF ACUTE LYMPHOBLASTIC LEUKEMIA -- A PEDIATRIC ONCOLOGY GROUP-WIDE PHASE II STUDY

National Cancer Institute (NCI)

vincristine

seizures

vincristine/seizures

Study of Cytolytic Viral Activation Therapy (CVAT) for Recurrent/Metastatic Nasopharyngeal Carcinoma

Phase II Trial of Pentostatin and Targeted Busulfan

Radiation Therapy and Chemotherapy in Treating Children With CNS Relapse From Acute Lymphoblastic Leukemia

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