• Efficacy of diphenhydramine hydrochloride, lorazepam, and dexamethasone in preventing CINV for 3 days after completion of the first course of emetogenic chemotherapy [ Designated as safety issue: No ]
• Severity of CINV as measured by the Adapted Rhodes Index of Nausea, Vomiting, and Retching--Measured by Child/Parent questionnaire [ Designated as safety issue: No ]

• 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

RATIONALE: Diphenhydramine, lorazepam, and dexamethasone may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. It is not yet known whether diphenhydramine, lorazepam, and dexamethasone are more effective than standard therapy in treating nausea and vomiting caused by chemotherapy.

PURPOSE: This randomized phase II trial is studying diphenhydramine, lorazepam, and dexamethasone to see how well they work compared with standard therapy in treating nausea and vomiting caused by chemotherapy in young patients with newly diagnosed cancer.

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 ondansetron 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 ondansetron 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 antiemetic 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.

• Nausea and Vomiting
• Unspecified Childhood Solid Tumor, Protocol Specific

• Drug: dexamethasone
• Drug: diphenhydramine hydrochloride
• Drug: lorazepam
• Drug: ondansetron hydrochloride

• Experimental: Patients receive ondansetron 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.
• Active Comparator: Patients receive ondansetron 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.

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
• No concurrent enrollment on another investigational protocol involving a study agent that is provided under an IND