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

Patients receive filgrastim SC QD started at 24 hours after completion of chemotherapy and stopped when ANC reaches at least 1,000/uL post nadir.

Patients receive filgrastim SC QD started on the first day after chemotherapy when ANC falls below 1,000/uL and stopped when ANC reaches at least 1,000/uL post nadir.

Childhood Choroid Plexus Tumor

Childhood Medulloblastoma

Childhood Pineoblastoma

Childhood Soft Tissue Sarcoma

Childhood Supratentorial Primitive Neuroectodermal Tumor

Neuroblastoma

Osteosarcoma

Retinoblastoma

Wilms Tumor and Other Childhood Kidney Tumors

Recurrent/Refractory Childhood Hodgkin Lymphoma

Unspecified Childhood Solid Tumor, Protocol Specific

Given SC once daily starting on day 1 after chemotherapy in Arm I (fixed) and on any day when ANC drops below 1000/mcl in Arm II (flexible)

filgrastim

Barbara Ann Karmanos Cancer Institute

Study of Fixed vs. Flexible Filgrastim to Accelerate Bone Marrow Recovery After Chemotherapy in Children With Cancer

Prospective and Randomized Study of Fixed Versus Flexible Prophylactic Administration of Granulocyte Colony-Stimulating Factor (G-CSF) in Children With Cancer

The analysis will be reported by displaying mean values (for each treatment in each sequence) as well as their differences, and 95% confidence intervals for the mean difference between treatments (adjusting for the period effect). Kaplan-Meier approach will be used.

Categorically scaled variables will be presented as numbers, ratios, and percentages. The McNemar's test will be used to assess the statistical significance of categorical data.

GLM procedure will be performed to examine differences between groups.

Univariately, continuously scaled variables will be presented as means, standard deviations, medians, ranges, and interquartile ranges.

Maxim Yankelevich

Principal Investigator

National Cancer Institute (NCI)

Children's Hospital of Michigan

Interferon starting at 7.5 million Units subQ 3 times a week and increasing on the designated schedule,as tolerated. Patients continue taking interferon for 1 year beyond CR. Patients who progress may crossover to receive EPOCH-R.

EPOCH-R every 3 weeks for up to 8 cycles, based on response.

Lymphomatoid Granulomatosis

Granulomatosis, Lymphomatoid

Non-Hodgkins Lymphoma

Lymphoproliferative Disorder

For LYG Grade 1 and 2: Interferon starting at 7.5 million Units subQ 3 times a week and increasing on the following schedule: 10 million U; 15 million U; 20 million U; 25 million U; and increased in 5 million U increments, as tolerated. Patients continue taking interferon for 1 year beyond CR.

Interferon

For LYG Grade 3: EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituxan) every 3 weeks for 6 cycles.

Rituxan and EPOCH

National Institutes of Health Clinical Center, 9000 Rockville Pike

Treatment and Natural History Study of Lymphomatoid Granulomatosis

Overall response will be classified as the following: complete remission, partial remission, disease progression or disease stabilization.

The response rate will be determined and reported along with a 95% confidence interval.

vincristine/cefalee

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

Study of Fixed vs. Flexible Filgrastim to Accelerate Bone Marrow Recovery After Chemotherapy in Children With Cancer

Treatment and Natural History Study of Lymphomatoid Granulomatosis

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