Beginning as soon as symptoms arise during chemoradiotherapy, patients receive Vaccinium myrtillus extract/Macleaya cordata alkaloids/Echinacea angustifolia extract granules PO QID. Patients may continue to receive Vaccinium myrtillus extract/Macleaya cordata alkaloids/Echinacea angustifolia extract granules for up to 4 weeks after completion of radiation therapy for a maximum of 11 weeks.

Beginning as soon as symptoms arise during chemoradiotherapy, patients receive placebo PO QID. Patients may continue to receive placebo for up to 4 weeks after completion of radiation therapy for a maximum of 11 weeks.

Mucositis

Recurrent Squamous Cell Carcinoma of the Hypopharynx

Recurrent Squamous Cell Carcinoma of the Larynx

Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity

Recurrent Squamous Cell Carcinoma of the Nasopharynx

Recurrent Squamous Cell Carcinoma of the Oropharynx

Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity

Recurrent Verrucous Carcinoma of the Larynx

Recurrent Verrucous Carcinoma of the Oral Cavity

Stage III Squamous Cell Carcinoma of the Hypopharynx

Stage III Squamous Cell Carcinoma of the Larynx

Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity

Stage III Squamous Cell Carcinoma of the Nasopharynx

Stage III Squamous Cell Carcinoma of the Oropharynx

Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity

Stage III Verrucous Carcinoma of the Larynx

Stage III Verrucous Carcinoma of the Oral Cavity

Stage IV Squamous Cell Carcinoma of the Hypopharynx

Stage IV Squamous Cell Carcinoma of the Nasopharynx

Stage IVA Squamous Cell Carcinoma of the Larynx

Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity

Stage IVA Squamous Cell Carcinoma of the Oropharynx

Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity

Stage IVA Verrucous Carcinoma of the Larynx

Stage IVA Verrucous Carcinoma of the Oral Cavity

Stage IVB Squamous Cell Carcinoma of the Larynx

Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity

Stage IVB Squamous Cell Carcinoma of the Oropharynx

Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity

Stage IVB Verrucous Carcinoma of the Larynx

Stage IVB Verrucous Carcinoma of the Oral Cavity

Tongue Cancer

placebo

quality-of-life assessment

questionnaire administration

Vaccinium myrtillus/Macleaya cordata/Echinacea angustifolia extract granules

Botanical Therapy in Treating Mucositis in Patients With Head and Neck Cancer Who Have Undergone Chemoradiation Therapy

A Phase 2 Placebo Controlled Randomized Study of the Effect of SAMITAL on Severity and Duration of Mucositis Induced by Chemoradiation for Head and Neck Cancer (HNC)

The 2 treatment groups will be compared using the Mantel-Haenszel test, stratified by disease site and type of therapy, using a two-sided test at the alpha= 0.10 level of significance. Since emphasis is placed on the accurate estimation of treatment effect for use in the planning of a future confirmatory trial, corresponding estimates of effect size will also be computed along with 90% confidence intervals.

The 2 treatment groups will be compared. The Mantel-Haenszel test, stratified by disease site and type of therapy, will be used for these comparisons.

The 2 treatment groups will be compared. Will be analyzed using Mann-Whitney U tests. All secondary analyses will be carried out using two-sided tests at the 10% level of significance.

Roswell Park Cancer Institute

National Cancer Institute (NCI)

Upper Respiratory Infections

10 ml BID for 10 consecutive days at the start of 3 consecutive 30 day periods

Echinacea purpurea 100 mg/ml in liquid formulation

10 ml PO BID for 10 consecutive days at the beginning of 3 consecutive 30 day periods

Effects of Echinacea in Children

Assessing the in Vivo Effect of Echinacea Purpurea on Markers of Immune Activities in Children

James Taylor

Professor, Pediatrics

University of Washington

National Center for Complementary and Integrative Health (NCCIH)

Patients received a 1-mg test dose of alemtuzumab, and the following day, alemtuzumab was administered at 10 mg/dose intravenously for 10 days

Alemtuzumab

Sex: Female, Male

Race/Ethnicity, Customized

Response to treatment at 3 months after the first dose of alemtuzumab. The parameters for hematologic improvement (HI) and complete response (CR) were defined according to the International Working Group (IWG) criteria. The IWG criteria for HI define specific responses of cytopenias in the 3 hematopoietic lineages: erythroid (HI-E), platelet (HI-P), and neutrophil (HI-N).7 The HIs are measured in patients with pretreatment abnormal values: hemoglobin level less than 110 g/L (11 g/dL) or RBC-transfusion dependence, platelet count less than 100 × 109/L or platelet-transfusion dependence, absolute neutrophil count (ANC) less than 1.0 × 109/L.
The parameters for CR include less than 5% marrow blasts without evidence of dysplasia and normalization of peripheral blood counts, including a hemoglobin level of 110 g/L (11 g/dL) or more (in patients not receiving erythropoietin or transfusions), a neutrophil count of 1.5 × 109/L or more, and a platelet count of 100 × 109/L.

Response to Treatment - Hematologic Improvement or Complete Response

Overall Study

Chris Hourigan MD

Myelodysplastic Syndromes

Alemtuzumab (Campath)

Alemtuzumab Is Safe and Associated With High Response Rates In Selected Patients With Myelodysplastic Syndrome

National Institutes of Health Clinical Center, 9000 Rockville Pike

A Pilot Study of Alemtuzumab (Campath[R]) in Patients With Myelodysplastic Syndrome

A Pilot Study of Alemtuzumab (Campath[R]) in Patients With Myelodysplastic Syndrome (MDS)

National Heart, Lung, and Blood Institute (NHLBI)