R(+)XK469 in Treating Patients With Advanced Neuroblastoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial is studying the side effects and best dose of R(+)XK469 in treating patients with advanced neuroblastoma. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Histologically confirmed high-risk neuroblastoma that has relapsed or is refractory to standard therapy

• No active brain metastases

• Previously treated brain metastases allowed if there is no requirement for corticosteroids or anticonvulsants

• Performance status - Karnofsky performance status 70-100% or Lansky score ≥ 70 for your pediatric patients

• More than 3 months

• WBC at least 3,000/mm^3

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Bilirubin normal (unless due to documented Gilbert's syndrome)

• Creatinine less than 1.5 times upper limit of normal

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other concurrent uncontrolled illness that would preclude study participation

• No ongoing or active infection

• No psychiatric illness or social situation that would preclude study participation

• No prior allergic reaction to compounds of similar chemical or biological composition to study drug (e.g., flurbiprofen or ibuprofen)

• No HIV-positive patients

• No concurrent biologic agents

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)

• No other concurrent chemotherapy

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy

• No concurrent palliative radiotherapy

• See Disease Characteristics

• Recovered from all prior therapy

• No other concurrent investigational agents

• No concurrent commercial agents or therapies directed at malignancy

• No concurrent combination anti-retroviral therapy for HIV-positive patients