Rebeccamycin Analog in Treating Children With Relapsed or Refractory Neuroblastoma

Neuroblastoma Clinical Trial

Official title:

A Pharmacokinetic-Guided Phase II Trial of the Rebeccamycin Analog NSC# 655649 in Pediatric Patients With Relapsed/Refractory Neuroblastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003737
• Other study ID #: 98-095
• Secondary ID: CDR0000066852NCI
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 24, 2013
• Start date: January 1999
• Est. completion date: September 2006

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analog in treating children who have relapsed or refractory neuroblastoma.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Drug:
• becatecarin

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response (complete response, very good partial response, or partial response)			No
Primary	Freedom from progression			No
Primary	Time to treatment failure			No
Secondary	Toxicity			Yes