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Phase II Study of Anti-GD2 3F8 Antibody and Biologic Response Modifiers for High-risk Neuroblastoma


Phase 2
N/A
N/A
Not Enrolling
Both
Neuroblastoma

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Trial Information

Phase II Study of Anti-GD2 3F8 Antibody and Biologic Response Modifiers for High-risk Neuroblastoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Nai-Kong V. Cheung, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

04-050

NCT ID:

NCT00089258

Start Date:

July 2004

Completion Date:

Related Keywords:

  • Neuroblastoma
  • localized unresectable neuroblastoma
  • disseminated neuroblastoma
  • regional neuroblastoma
  • stage 4S neuroblastoma
  • recurrent neuroblastoma
  • Neuroblastoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021