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Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma - Article


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Isotretinoin

Accutane; Amnesteem; Claravis; Sotret




Clinical Trial: Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma

This study is no longer recruiting patients.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy plus etoposide in treating patients who have neuroblastoma.

Condition Treatment or Intervention Phase
regional neuroblastoma
disseminated neuroblastoma
recurrent neuroblastoma
localized unresectable neuroblastoma
 Drug: etoposide
 Drug: isotretinoin
 Drug: monoclonal antibody 3F8
 Procedure: antibody therapy
 Procedure: biological response modifier therapy
 Procedure: chemotherapy
 Procedure: monoclonal antibody therapy
Phase II

MedlinePlus related topics:  Neuroblastoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Monoclonal Antibody 3F8, Etoposide, and Isotretinoin in Patients With High-Risk Neuroblastoma

Further Study Details: 

OBJECTIVES:

OUTLINE: Patients are stratified according to disease status (evaluable but not measurable vs second or subsequent remission with no measurable or evaluable disease).

Patients receive monoclonal antibody 3F8 (MOAB 3F8) IV over 1.5 hours once daily on days 1-10 and oral etoposide once daily on days 29-49. Treatment repeats every 8 weeks for 4 courses in the absence of disease progression, human anti-mouse antibody (HAMA) response, or unacceptable toxicity.

If HAMA fails to develop after completion of 4 courses of MOAB 3F8, patients continue treatment with MOAB 3F8 on days 1-5 every 8 weeks until HAMA reaches greater than 1,000 U/mL or until month 24, whichever occurs first.

Beginning after completion of 4 courses of etoposide and MOAB 3F8 or if HAMA develops, patients receive oral isotretinoin twice daily for 14 days followed by at least a 14-day rest. Treatment repeats for a total of 6 courses.

PROJECTED ACCRUAL: A total of 50 patients (25 per stratum) will be accrued for this study within 5 years.

Eligibility

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • High-risk neuroblastoma by:
  • Histopathology OR
  • Bone marrow involvement plus elevated urinary catecholamines
  • Prior tumor progression on standard chemotherapy and poor long-term prognosis as indicated by 1 or more of the following:
  • N-myc amplification in tumor cells
  • Diploid chromosomal content plus lp loss of heterozygosity in tumor cells
  • Distant skeletal metastases
  • Unresectable primary tumor infiltrating across the midline
  • More than 10% tumor cells in bone marrow
  • Less than 30% chance of long-term progression-free survival
  • Evaluable (microscopic marrow metastasis, elevated tumor markers, abnormal bone scan or MIBG or PET scan) but not measurable (CT scan, MRI) disease documented at least 4 weeks after completion of prior systemic therapy
  • No rapidly progressive disease as defined by 1 or more of the following:
  • Serum lactic dehydrogenase greater than 1.5 times upper limit of normal due to tumor
  • An opiate requirement for pain from tumor
  • Greater than 25% increase in tumor by successive imaging studies
  • Life expectancy less than 8 weeks
  • Second or subsequent remission after chemotherapy and/or radiotherapy allowed provided there is less than 30% chance of survival
  • No prior myelodysplastic syndromes or leukemia

PATIENT CHARACTERISTICS: Age:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • See Disease Characteristics
  • At least 8 weeks

Hematopoietic:

  • Not specified

Hepatic:

Renal:

  • No grade 3 or worse renal toxicity
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

Pulmonary:

Other:

  • Not pregnant
  • No grade 3 or worse gastrointestinal toxicity
  • No grade 3 or worse neurologic system toxicity
  • No grade 4 hearing deficit
  • No active life-threatening infection
  • No prior exposure to mouse antibodies and human anti-mouse antibody greater than 1,000 ELISA units/mL
  • No allergy to mouse proteins

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • See Disease Characteristics

Location Information


New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Nai-Kong V. Cheung, MD, PhD,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067333; MSKCC-IRB-99033; NCI-G99-1599
Record last reviewed:  November 2003
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004110
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources



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December 4, 2008



Page Updated: June 1, 2005
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