• 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
  

OBJECTIVES:

Primary

• 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

• 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.

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.

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

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

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

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 5HT_3 antagonists