Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Diphenhydramine, Lorazepam, and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy in Young Patients With Newly Diagnosed Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Supportive care Active 8 to 18 NCI MCC-0503 HLMCC 0503, NCT00429702

Objectives

Primary

1. Compare the degree of chemotherapy-induced nausea and vomiting (CINV) in pediatric patients with newly diagnosed cancer treated with diphenhydramine hydrochloride, lorazepam, and dexamethasone vs standard antiemetic therapy during the first course of emetogenic chemotherapy.

Secondary

1. Compare the degree of CINV during the first 3 days after completion of the first course of emetogenic chemotherapy in patients treated with these antiemetic regimens.

Entry Criteria

Disease Characteristics:

• Newly diagnosed cancer
  • Chemotherapy naive



• Scheduled to receive moderately or highly emetogenic chemotherapy as an inpatient



• Scheduled for placement of a double-lumen catheter (to be used during chemotherapy treatment)



• No CNS disease

Prior/Concurrent Therapy:

• See Disease Characteristics
• No prior chemotherapy
• No prior stem cell transplantation
• No other concurrent steroids (i.e., no steroids included in the chemotherapy regimen)
• No other concurrent 5HT₃ antagonists

Patient Characteristics:

• No contraindication to the use of dexamethasone (e.g., diabetes)
• No hepatic and/or renal failure
• No known allergy or hypersensitivity to any of the study medications
• Not pregnant or nursing
• Fertile patients must use effective contraception

Expected Enrollment

A total of 180 patients will be accrued for this study.

Outcomes

Efficacy of diphenhydramine hydrochloride, lorazepam, & dexamethasone in preventing chemotx-induced nausea & vomiting (CINV) as measured by proportion of patients requiring rescue medication for breakthrough nausea or emesis during chemotx

Efficacy of diphenhydramine hydrochloride, lorazepam, and dexamethasone in preventing CINV for 3 days after completion of the first course of emetogenic chemotherapy
Severity of CINV as measured by the Adapted Rhodes Index of Nausea, Vomiting, and Retching--Measured by Child/Parent questionnaire

Outline

This is a randomized, prospective, double-blind, multicenter study. Patients are stratified according to the emetogenic potential of their chemotherapy regimen (high vs moderate). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive granisetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.



• Arm II: Patients receive granisetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.

In both arms, treatment continues during the first course of chemotherapy. Patients may also receive rescue medication to control breakthrough nausea or emesis.

Patients and their parents complete the Adapted Rhodes Index of Nausea, Vomiting, and Retching- Measured by Child/Parent questionnaire once before beginning chemotherapy, twice daily during chemotherapy, and for 3 days after completion of chemotherapy.

Trial Contact Information

Trial Lead Organizations

H. Lee Moffitt Cancer Center CCOP Research Base

Haydar Frangoul, MD, Protocol chair		Ph: 615-936-1782; 800-811-8480 Email: haydar.frangoul@vanderbilt.edu

U.S.A.
Florida
	Fort Myers
	Children's Hospital of Southwest Florida
		Emad Salman, MD	Ph:  239-343-6959
			Email: carolyn.bell@leememorial.org
	Orlando
	Arnold Palmer Hospital for Children
		Don Eslin, MD	Ph:  321-841-1633
			Email: rebecca.martin@orhs.org
	Tampa
	St. Joseph's Children's Hospital of Tampa
		Cameron K. Tebbi, MD	Ph:  813-870-4387
			Email: pamela.neu@baycare.org
Puerto Rico
	Santurce
	San Jorge Children's Hospital
		Luis Clavell, MD	Ph:  787-728-1575
			Email: dmorales@sjcms.com

Registry Information
Official Title		Phase II Randomized, Double-Blinded Study of an Antiemetic Pump, Using Benadryl®, Avitan® and Decadron® (BAD), for Children Receiving Moderately or Highly Emetogenic Chemotherapy [BAD]
Trial Start Date		2007-10-24
Registered in ClinicalTrials.gov		NCT00429702
Date Submitted to PDQ		2006-12-15
Information Last Verified		2008-09-03
NCI Grant/Contract Number		CA76292