A Pharmacokinetic-Guided Phase II Trial of the Rebeccamycin Analog NSC# 655649 in Pediatric Patients With Relapsed/Refractory Neuroblastoma
N/A
18 Years
Both
Neuroblastoma
Trial Information
A Pharmacokinetic-Guided Phase II Trial of the Rebeccamycin Analog NSC# 655649 in Pediatric Patients With Relapsed/Refractory Neuroblastoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Response (complete response, very good partial response, or partial response)
Safety Issue:
No
Principal Investigator
Tanya Trippett, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
98-095
NCT ID:
NCT00003737
Start Date:
January 1999
Completion Date:
September 2006
Related Keywords:
- Neuroblastoma
- recurrent neuroblastoma
- Neuroblastoma
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
