Rebeccamycin Analog in Treating Children With Relapsed or Refractory Neuroblastoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00003737
First received: November 1, 1999
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Neuroblastoma
Drug: becatecarin
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Pharmacokinetic-Guided Phase II Trial of the Rebeccamycin Analog NSC# 655649 in Pediatric Patients With Relapsed/Refractory Neuroblastoma

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Response (complete response, very good partial response, or partial response) [ Designated as safety issue: No ]
  • Freedom from progression [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: January 1999
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003737

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Tanya Trippett, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003737     History of Changes
Other Study ID Numbers: 98-095, CDR0000066852, NCI-T98-0041
Study First Received: November 1, 1999
Last Updated: June 24, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
recurrent neuroblastoma

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on July 22, 2014