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Biological Therapy in Treating Patients With Neuroblastoma That Has Not Responded to Previous Treatment

Primary Purpose

Neuroblastoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
beta-glucan
monoclonal antibody 3F8
sargramostim
isotretinoin
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroblastoma focused on measuring localized unresectable neuroblastoma, disseminated neuroblastoma, regional neuroblastoma, stage 4S neuroblastoma, recurrent neuroblastoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of neuroblastoma, as defined by 1 of the following: Histologically confirmed disease Bone marrow metastases plus high urine catecholamines High-risk disease meeting 1 of the following stage criteria: Stage IV, with 1 of the following: Any age with MYCN amplification > 18 months of age without MYCN amplification Stage III, with both of the following: Any age with MYCN amplification Unresectable disease Stage 4S with MYCN amplification Measurable or evaluable soft tissue disease Relapsed disease resistant to standard induction chemotherapy and salvage therapy PATIENT CHARACTERISTICS: Age Any age Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic No severe hepatic toxicity ≥ grade 3 Renal No severe renal toxicity ≥ grade 3 Cardiovascular No severe cardiac toxicity ≥ grade 3 Pulmonary No severe pulmonary toxicity ≥ grade 3 Other Not pregnant Negative pregnancy test No severe neurologic toxicity ≥ grade 3 No severe gastrointestinal toxicity ≥ grade 3 No other severe major organ dysfunction except ototoxicity No history of allergy to mouse proteins No active life-threatening infection No human anti-mouse antibody titer > 1,000 ELISA units/mL PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Disease response as assessed by PT-PC at the end of 4 courses

Secondary Outcome Measures

Full Information

First Posted
August 4, 2004
Last Updated
January 15, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00089258
Brief Title
Biological Therapy in Treating Patients With Neuroblastoma That Has Not Responded to Previous Treatment
Official Title
Phase II Study of Anti-GD2 3F8 Antibody and Biologic Response Modifiers for High-risk Neuroblastoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Monoclonal antibodies, such as monoclonal antibody 3F8, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Beta-glucan, isotretinoin, and sargramostim may increase the effectiveness of monoclonal antibody 3F8 by making tumor cells more sensitive to the monoclonal antibody. Combining different types of biological therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving beta-glucan, isotretinoin, and sargramostim together with monoclonal antibody 3F8 works in treating patients with neuroblastoma that has not responded to previous treatment.
Detailed Description
OBJECTIVES: Determine the efficacy of beta-glucan, isotretinoin, and sargramostim (GM-CSF) in enhancing monoclonal antibody 3F8-mediated ablation in patients with high-risk refractory neuroblastoma. Determine the antitumor activity of this regimen, in terms of assessing disease status in the bone marrow by real-time quantitative reverse transcription polymerase chain reaction, in these patients. Determine the toxicity of this regimen in these patients. OUTLINE: This is an open-label study. Patients are stratified according to refractory disease (primary refractory [never had disease progression or disease recurrence] vs secondary refractory [recurrent disease that did not respond completely to reinduction therapy]). Courses 1 and 2: Patients receive sargramostim (GM-CSF) subcutaneously once daily on days -5 to 11. Patients also receive oral beta-glucan once daily on days -2 to 11 and monoclonal antibody (MOAB) 3F8 IV over 30-90 minutes on days 0-4 and 7-11. Courses 3 and 4: Patients receive GM-CSF, beta-glucan, and MOAB 3F8 as above. Patients also receive oral isotretinoin twice daily on days -2 to 11. Treatment repeats every 2-4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 27-74 patients (10-33 for stratum 1 and 17-41 for stratum 2) will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma
Keywords
localized unresectable neuroblastoma, disseminated neuroblastoma, regional neuroblastoma, stage 4S neuroblastoma, recurrent neuroblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
beta-glucan
Intervention Type
Biological
Intervention Name(s)
monoclonal antibody 3F8
Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Type
Drug
Intervention Name(s)
isotretinoin
Primary Outcome Measure Information:
Title
Disease response as assessed by PT-PC at the end of 4 courses

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of neuroblastoma, as defined by 1 of the following: Histologically confirmed disease Bone marrow metastases plus high urine catecholamines High-risk disease meeting 1 of the following stage criteria: Stage IV, with 1 of the following: Any age with MYCN amplification > 18 months of age without MYCN amplification Stage III, with both of the following: Any age with MYCN amplification Unresectable disease Stage 4S with MYCN amplification Measurable or evaluable soft tissue disease Relapsed disease resistant to standard induction chemotherapy and salvage therapy PATIENT CHARACTERISTICS: Age Any age Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic No severe hepatic toxicity ≥ grade 3 Renal No severe renal toxicity ≥ grade 3 Cardiovascular No severe cardiac toxicity ≥ grade 3 Pulmonary No severe pulmonary toxicity ≥ grade 3 Other Not pregnant Negative pregnancy test No severe neurologic toxicity ≥ grade 3 No severe gastrointestinal toxicity ≥ grade 3 No other severe major organ dysfunction except ototoxicity No history of allergy to mouse proteins No active life-threatening infection No human anti-mouse antibody titer > 1,000 ELISA units/mL PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nai-Kong V. Cheung, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Biological Therapy in Treating Patients With Neuroblastoma That Has Not Responded to Previous Treatment

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