A Pharmacokinetic-Guided Phase II Trial of the Rebeccamycin Analog NSC# 655649 in Pediatric Patients With Relapsed/Refractory Neuroblastoma
becatecarin
Neoplasms+7
+ Neoplasms by Histologic Type
+ Neoplasms, Germ Cell and Embryonal
Treatment Study
Summary
Study start date: January 1, 1999
Actual date on which the first participant was enrolled.OBJECTIVES: Determine the response rate to rebeccamycin analogue in children with relapsed or refractory neuroblastoma. Determine the toxicity of this drug in these patients. Identify and establish in vitro biologic correlates of clinical responses and toxicity of this drug in these patients. OUTLINE: Patients receive rebeccamycin analogue IV over 1 hour once on days 1-5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: This study will accrue up to 30 patients within 1.5 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically proven relapsed or refractory neuroblastoma Measurable disease PATIENT CHARACTERISTICS: Age: Children Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5 mg/dL SGOT and SGPT less than 2.5 times upper limit of normal (ULN) Adequate liver function unless due to disease Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min Adequate renal function unless due to disease Other: No other serious concurrent illness No active uncontrolled infection Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Recovered from prior immunotherapy Prior autologous bone marrow transplantation allowed No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No other concurrent systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy Surgery: Not specified
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Memorial Sloan-Kettering Cancer Center
New York, United StatesOpen Memorial Sloan-Kettering Cancer Center in Google Maps