Neoplasms

All Conditions

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Nausea

Vomiting

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Embryonal Tumor With Multilayered Rosettes

Subependymal Giant Cell Astrocytoma

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Cerebral Astrocytoma, Childhood

Childhood Supratentorial Embryonal Tumor, Not Otherwise Specified

Antiemetics

Dermatologic Agents

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antineoplastic Agents

Emetics

Ondansetron

Granisetron

Dexamethasone

Cisplatin

Dexamethasone acetate

Patients wear Sea-Band acupressure wristbands on each wrist beginning approximately 30 minutes prior to the first cisplatin-containing chemotherapy course and continually for 24 hours after the last chemotherapy dose (acute phase), and for a maximum of 7 days or until the next chemotherapy course starts (delayed phase). Patients are allowed to take bands off intermittently (up to 4 times a day, for no more than 15 minutes each time) to relieve pressure or to bathe. Patients also receive standard of care anti-emetic prophylaxis comprising granisetron, ondansetron, or dexamethasone during chemotherapy according to institutional or physician preference.

Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I.

Real Acupressure Band

Placebo Acupressure Band

Thomas Williams McLean, MD

Lee Dupuis, PhD

RATIONALE: Acupressure wristbands may prevent or reduce nausea and caused by chemotherapy. It is not yet known whether standard care is more effective with or without acupressure wristbands in controlling acute and delayed nausea.

PURPOSE: This randomized phase III trial is studying how well acupressure wristbands work with or without standard care in controlling nausea in young patients receiving highly emetogenic chemotherapy.

OBJECTIVES:

Primary

* To compare the control of chemotherapy-induced nausea (CIN) in the acute phase provided by a 5-HT3 antagonist combined with acupressure versus placebo acupressure in children 4 to 18 years of age being treated with chemotherapy including cisplatin ≥ 50 mg/m2/dose, ifosfamide plus etoposide/doxorubicin, or cyclophosphamide plus an anthracycline.

Secondary

* To compare the control of CIN in the delayed phase provided by a 5-HT3 antagonist combined with acupressure versus placebo acupressure in children 4 to 18 years of age being treated with chemotherapy including cisplatin ≥ 50 mg/m2/dose, ifosfamide plus etoposide/doxorubicin, or cyclophosphamide plus an anthracycline.
* To compare the control of chemotherapy-induced vomiting and retching (CIV) in the acute and delayed phases provided by a 5-HT3 antagonist combined with acupressure versus placebo acupressure in children 4 to 18 years of age being treated with chemotherapy including cisplatin ≥ 50 mg/m2/dose, ifosfamide plus etoposide/doxorubicin, or cyclophosphamide plus an anthracycline.

OUTLINE: This is a multicenter study. Patients are stratified according chemotherapy regimen and anti-emetic Regimen 5-HT3 agonists (ondansetron or granisetron.) Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients wear Sea-Band acupressure wristbands on each wrist beginning approximately 30 minutes prior to the first cisplatin-containing chemotherapy course and continually for 24 hours after the last chemotherapy dose (acute phase), and for a maximum of 7 days or until the next chemotherapy course starts (delayed phase). Patients are allowed to take bands off intermittently (up to 4 times a day, for no more than 15 minutes each time) to relieve pressure or to bathe. Patients also receive standard of care anti-emetic prophylaxis comprising granisetron, ondansetron, or dexamethasone during chemotherapy according to institutional or physician preference.
* Arm II: Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I.

Patients, parents, or guardians are instructed to complete an impatient and an outpatient diaries on nausea severity and the time of each emetic episode. Patients, parents, or guardians also complete a questionnaire about acupressure at the end of the study.

Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy

Randomized Controlled Trial of Acupressure to Control Chemotherapy-Induced Nausea (CIN) in Children Receiving Highly Emetogenic Chemotherapy

CIN = Chemotherapy-Induced Nausea. The acute phase began with administration of the first chemotherapy dose of a chemotherapy block and continued until 24 hours after administration of the last chemotherapy dose of the block. Acute Phase - bands will be worn on each day of the chemotherapy course and for 24 hours after the last chemotherapy dose. Nausea severity during the acute phase of chemotherapy is defined as the maximum PeNAT (Pediatric Nausea Assessment Tool) score observed during each 24 hour period. The possible scores for the pediatric nausea assessment tool are no nausea, mild nausea, moderate nausea, severe nausea. Only patients who contributed at least 1 PeNAT score during the acute phase were included. The duration of the acute phase varied with chemotherapy regimen, according to study design.

CIN = Chemotherapy-Induced Nausea. The delayed phase began at the end of the acute phase and continued until the first chemotherapy dose of the next chemotherapy block. Delayed Phase - Bands will continue to be worn for a maximum of 7 days or until the next chemotherapy cycle starts, whichever comes first. Nausea severity is defined as the maximum PeNAT (Pediatric Nausea Assessment Tool) score observed during each 24 hour period. The possible scores for the pediatric nausea assessment tool are no nausea, mild nausea, moderate nausea, severe nausea. Only patients who contributed at least 1 PeNAT score during the delayed phase were included.

CIV = Chemotherapy-Induced Vomiting. Total Duration of Study includes both acute and delayed phases. Acute Phase - bands will be worn on each day of the chemotherapy course and for 24 hours after the last chemotherapy dose. Delayed Phase - Bands will continue to be worn for a maximum of 7 days or until the next chemotherapy cycle starts, whichever comes first. A breakthrough antiemetic agent is defined as a medication that is administered or taken in order to relieve or treat (rather than prevent) nausea or vomiting. An antiemetic agent that is prescribed and/or administered on an "as needed" basis is considered to be a breakthrough antiemetic. Complete CIV Control during the acute and delayed phases is defined as no emetic episodes and no breakthrough anti-emetic agents administered during the phase of interest. Partial CIV Control is defined as 1 or 2 emetic episodes in any 24 ho

National Cancer Institute (NCI)

University of South Florida

Adverse events could spontaneously be communicated by the patient/family and/or elicited via the Final Questionnaire.

Patients wear Sea-Band acupressure wristbands on each wrist beginning approximately 30 minutes prior to the first cisplatin-containing chemotherapy course and continually for 24 hours after the last chemotherapy dose (acute phase), and for a maximum of 7 days or until the next chemotherapy course starts (delayed phase). Patients are allowed to take bands off intermittently (up to 4 times a day, for no more than 15 minutes each time) to relieve pressure or to bathe. Patients also receive standard of care anti-emetic prophylaxis comprising granisetron, ondansetron, or dexamethasone during chemotherapy according to institutional or physician preference.

Real Acupressure Band: Acupressure wristband

Arm I- Real Acupressure Bands

Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I.

Placebo Acupressure Band: Sham wristband

Arm II- Placebo Acupressure Bands

Total

Age, Continuous

Sex: Female, Male

Diagnosis

93 participants were allocated to acupressure bands and 83 received the intervention. 94 participants were allocated to the placebo bands and 82 received the intervention.

Thomas W. McLean, MD

Day 1

Day 2

Day 3

Days 4-7

The overall number of patients analyzed is 83 for Arm I and 82 for Arm II. Patients analyzed include the total number of patients that reported at least 1 PeNAT (Pediatric Nausea Assessment Tool) score on that day. The duration of the acute phase varied with chemotherapy regimen, according to study design. The number of patients receiving chemotherapy for longer than 3 days diminished each day, so days 4-7 were collapsed and considered a single day.

Efficacy of Treatment on CIN During Acute Phase of Chemotherapy

Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy

Acute Phase

Delayed Phase

The overall number of participants analyzed is 83 participants in Arm I and 82 participants in Arm II. In the acute phase, 165 patients provided at least 1 PeNAT (Pediatric Nausea Assessment Tool) score. In the delayed phase, 144 patients contributed at least 1 PeNAT score.

Comparison of Control of CIV During the Acute and Delayed Phase of Chemotherapy

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Brain Neoplasms

Spinal Cord Neoplasms

Pinealoma

Rhabdomyosarcoma

Choriocarcinoma

Pineocytoma

Brain Tumor, Childhood

Malignant Germ Cell Tumor

This is a dose escalation study. Study participants will receive .6 or 1.2 mg/kg orally twice daily or 1.2, 1.5, or 2.0 mg/kg orally three times daily for four consecutive weeks (a course). In the absence of unacceptable toxicity or disease progression, treatment may continue for up to 12 courses (approximately one year)

VEGF inhibitor PTC299

Roger J. Packer, MD

RATIONALE: PTC299 may stop the growth of tumor cells by blocking blood flow to the tumor.

PURPOSE: This phase I trial is studying the side effects and the best dose of PTC299 in treating young patients with recurrent or refractory primary central nervous system tumors.

OBJECTIVES:

Primary

* To estimate the maximum-tolerated dose and the recommended phase II dose of VEGF inhibitor PTC299 (PTC299) in pediatric patients with recurrent or progressive primary central nervous system (CNS) tumors.
* To evaluate and characterize the adverse events associated with this regimen in these patients.
* To evaluate and characterize the pharmacokinetics and pharmacodynamics of this regimen in these patients.

Secondary

* To investigate the relationships between PTC299 plasma exposure and other outcomes measures.
* To evaluate the antitumor activity of this regimen in these patients.
* To evaluate changes in angiogenic and inflammatory markers in the blood and the relationship between these changes and other outcome measures.
* To obtain preliminary evidence of biologic activity of PTC299 by using magnetic resonance diffusion to assess tumor cellularity.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive oral VEGF inhibitor PTC299 twice or thrice daily. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and periodically during study for pharmacokinetic and pharmacodynamic studies by ELISA.

After completion of study therapy, patients are followed up for 30 days.

PTC299 in Treating Young Patients With Refractory or Recurrent Primary Central Nervous System Tumors

Phase I and Pharmacokinetic Trial of PTC299 in Pediatric Patients With Refractory or Recurrent CNS Tumors

Brain images to assess partial or complete response are performed every 8 weeks after the first dose of the study drug.

Blood samples from study participants will be collected on day 1 and day 28 of course 1 for standard full pharmacokinetic studies.

Blood samples will be collected and analyzed on Day 1 of pre-AM dosing at baseline and at the discontinuation or completion of treatment. Changes from baseline in blood angiogenic markers and cytokines (VEGF-A, VEGF-C, VEGF-D, PlGF, VEGFR-1, VEGFR-2, IL-6, and IL-8) will be assessed.

PTC Therapeutics

Pediatric Brain Tumor Consortium

Blood and Lymph Conditions

Immune System Diseases

Diseases and Abnormalities at or Before Birth

Neoplasm Metastasis

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Congenital Abnormalities

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Leukemia, Prolymphocytic

Meningeal Neoplasms

Sarcoma, Ewing

Neuroectodermal Tumors, Primitive, Peripheral

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Leukemia, Hairy Cell

Leukemia, Large Granular Lymphocytic

Leukemia, Mast-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Graft Versus Host Disease

Acute Non Lymphoblastic Leukemia

Chronic Lymphocytic Leukemia

Chronic Myeloid Leukemia

Acute Graft Versus Host Disease

Childhood Acute Lymphoblastic Leukemia

Brain Tumor, Adult

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Hairy Cell Leukemia

Aggressive NK Cell Leukemia

T-cell Large Granular Lymphocyte Leukemia

questionnaire administration

psychosocial assessment and care

Elizabeth Fox, MD

RATIONALE: Gathering information about why patients or their guardians agree or decline to participate in the optional pharmacokinetic portion of a phase I treatment study may help doctors plan clinical trials in the future.

PURPOSE: This clinical trial is looking at decision making about participating in pharmacokinetic studies in patients enrolled in a phase I treatment clinical trial.

OBJECTIVES:

* To use a simple 2-page survey to gather preliminary information on why patients or parents/guardians (if patient is a minor) do or do not agree to participate in the optional pharmacokinetic portion of a phase I treatment study while consenting to participate in the phase I treatment study.

OUTLINE: This is a multicenter study.

Patients or parents/guardians (if patient is a minor) complete a short questionnaire on the reasons for agreeing/declining to participation in the optional pharmacokinetic sampling component of the phase I clinical trial.

Patient demographics and other relevant information are collected.

Decision Making About Participating in Pharmacokinetic Studies in Patients Enrolled in a Phase I Treatment Clinical Trial

A Pharmacokinetic Participation Questionnaire Study

Children's Oncology Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy	NCT01346267	Central Nervous... Chemotherapy-in... Unspecified Chi...	Real Acupressur... Placebo Acupres...	4 Years - 18 Years	University of South Florida
Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy	NCT01346267	Central Nervous... Chemotherapy-in... Unspecified Chi...	Real Acupressur... Placebo Acupres...	4 Years - 18 Years	University of South Florida
Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy	NCT01346267	Central Nervous... Chemotherapy-in... Unspecified Chi...	Real Acupressur... Placebo Acupres...	4 Years - 18 Years	University of South Florida
PTC299 in Treating Young Patients With Refractory or Recurrent Primary Central Nervous System Tumors	NCT01158300	Brain and Centr...	VEGF inhibitor ...	3 Years - 21 Years	Pediatric Brain Tumor Consortium
Decision Making About Participating in Pharmacokinetic Studies in Patients Enrolled in a Phase I Treatment Clinical Trial	NCT00890435	Brain and Centr... Leukemia Unspecified Adu... Unspecified Chi...	questionnaire a... psychosocial as...	18 Years -	Children's Oncology Group
Decision Making About Participating in Pharmacokinetic Studies in Patients Enrolled in a Phase I Treatment Clinical Trial	NCT00890435	Brain and Centr... Leukemia Unspecified Adu... Unspecified Chi...	questionnaire a... psychosocial as...	18 Years -	Children's Oncology Group

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