Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma
Condition: Neuroblastoma
MeSH terms: Neuroblastoma
Intervention: anti-GD2 murine IgG3 monoclonal antibody 3F8; anti-GD2 murine IgG3 monoclonal antibody 3F8
Intervention description: The total dosage of 3F8 per cycle is the same as in prior trials (100 mg/m2), administered at 20 mg/m2/day and infused over ~1.5 hr or less (0.5 hr is customary), with analgesics and antihistamines used as needed for expected side-effects. 3F8 is started ~1 hr after completion of GM-CSF administration. GM-CSF is dosed at 250 mcg/m2/day from day -5 to day +1 (Wednesday to Tuesday is customary) , and is 500 mcg/m2/day thereafter (i.e., on days +2 to +4; Wednesday to Friday), as in the predecessor protocol.18,74 Patients come off study if progressive disease occurs or if there is life-threatening grade 4 toxicity from 3F8; otherwise, patients will receive a minimum of 4 cycles of treatment and will continue treatment through 24 months. It is expected that patients will receive ~10 cycles.; The total dosage of 3F8 per cycle is the same as in prior trials (100 mg/m2), administered at 20 mg/m2/day and infused over ~1.5 hr or less (0.5 hr is customary), with analgesics and antihistamines used as needed for expected side-effects. 3F8 is started ~1 hr after completion of GM-CSF administration. GM-CSF is dosed at 250 mcg/m2/day from day -5 to day +1 (Wednesday to Tuesday is customary) , and is 500 mcg/m2/day thereafter (i.e., on days +2 to +4; Wednesday to Friday), as in the predecessor protocol.18,74 Patients come off study if progressive disease occurs or if there is life-threatening grade 4 toxicity from 3F8; otherwise, patients will receive a minimum of 4 cycles of treatment and will continue treatment through 24 months. It is expected that patients will receive ~10 cycles.
Intervention MeSH terms: Carbamide Peroxide; Antineoplastic Agents, Immunological; Irinotecan; Temozolomide; Molgramostim; Isotretinoin; Antibodies; Immunoglobulins; Antibodies, Monoclonal; Sargramostim; Immunoglobulin G
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 291.0
Sex: All
Healthy volunteers: No
Keywords: disseminated neuroblastoma; localized unresectable neuroblastoma; recurrent neuroblastoma; regional neuroblastoma; stage 4S neuroblastoma

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.
      Colony-stimulating factors, such as sargramostim, may increase the number of immune cells
      found in bone marrow or peripheral blood. Combining monoclonal antibody 3F8 with sargramostim
      may cause a stronger immune response and kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combining monoclonal antibody 3F8 with
      sargramostim in treating patients who have neuroblastoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of neuroblastoma by histopathology OR bone marrow metastases and high urine
             catecholamine levels

          -  Disease must meet risk-related treatment guidelines and any of the following
             International Neuroblastoma Staging System stages:

               -  Stage 4 with (any age) OR without (> 18 months of age of age) MYCN amplification

               -  MYCN-amplified other than stage 1

          -  No evidence of disease (i.e., in complete response/remission or very good partial
             response/remission) OR disease resistant to standard therapy (i.e., incomplete
             response in bone marrow)

          -  No progressive disease or MIBG-avid soft tissue tumor

        PATIENT CHARACTERISTICS:

          -  No existing renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal
             toxicity ≥ grade 3

          -  No human anti-mouse antibody (HAMA) titer greater than 1,000 Elisa units/mL

          -  No history of allergy to mouse proteins

          -  No active life-threatening infection

          -  Not pregnant

          -  Negative pregnancy test

        PRIOR CONCURRENT THERAPY:

          -  Not specified