Clinical Trials /

Humanized 3F8 Monoclonal Antibody (Hu3F8) When Combined With Interleukin-2 in Patients With High-Risk Neuroblastoma and GD2-positive Solid Tumors

NCT01662804

Description:

The purpose of this study is to find out if "humanized 3F8" (Hu3F8) when combined with interleukin-2 (rIL2) is safe for treating neuroblastoma and other cancers. A phase 1 study means the investigators are trying to find out what side effects happen when higher and higher doses of a drug are used. The investigators want to find out what effects, good and/or bad, Hu3F8 combined with rIL2 has on cancer. The amount of Hu3F8 that patients gets will depend on when they start treatment on this study. The amount of rIL2 will be the same for all patients. The investigators also want to find out more about how Hu3F8 works and how effective it is in attacking the disease when combined with rIL2.

Related Conditions:
  • Malignant Solid Tumor
  • Neuroblastoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Humanized 3F8 <span class="go-doc-concept go-doc-intervention">Monoclonal Antibody</span> (Hu3F8) When Combined With <span class="go-doc-concept go-doc-intervention">Interleukin-2</span> in Patients With High-Risk <span class="go-doc-concept go-doc-disease">Neuroblastoma</span> and GD2-positive Solid Tumors

Title

  • Brief Title: Humanized 3F8 Monoclonal Antibody (Hu3F8) When Combined With Interleukin-2 in Patients With High-Risk Neuroblastoma and GD2-positive Solid Tumors
  • Official Title: Phase I Study of Humanized 3F8 Monoclonal Antibody (Hu3F8) When Combined With Interleukin-2 in Patients With High-Risk Neuroblastoma and GD2-positive Solid Tumors
  • Clinical Trial IDs

    NCT ID: NCT01662804

    ORG ID: 12-116

    Trial Conditions

    Neuroblastoma

    Trial Interventions

    Drug Synonyms Arms
    3F8 Monoclonal Antibody Combined with Interleukin-2 hu3F8 and rIL-2

    Trial Purpose

    The purpose of this study is to find out if "humanized 3F8" (Hu3F8) when combined with
    interleukin-2 (rIL2) is safe for treating neuroblastoma and other cancers. A phase 1 study
    means the investigators are trying to find out what side effects happen when higher and
    higher doses of a drug are used.

    The investigators want to find out what effects, good and/or bad, Hu3F8 combined with rIL2
    has on cancer. The amount of Hu3F8 that patients gets will depend on when they start
    treatment on this study. The amount of rIL2 will be the same for all patients. The
    investigators also want to find out more about how Hu3F8 works and how effective it is in
    attacking the disease when combined with rIL2.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    hu3F8 and rIL-2 Experimental This phase I single arm trial assesses the toxicity of escalating doses of hu3F8 (day 1 and day 8) in the presence of 6 106 U rIL-2/m2/d x 5 days sc (day 8 through day 12). These 2 doses of hu3F8 and 5 doses of rIL-2 constitute a treatment cycle. 3F8 Monoclonal Antibody Combined with Interleukin-2

    Eligibility Criteria

    Inclusion Criteria:

    - Patients must have either (1) a diagnosis of NB as defined by international
    criteria,84 i.e., histopathology (confirmed by the MSKCC Department of Pathology) or
    BM metastases plus high urine catecholamine levels, or (2) a tumor that is
    GD2-positive.

    o A non-NB tumor is defined as GD2-positive by immunostaining with m3F8. If fresh or
    frozen tumor is not available for immunostaining, patients will be considered
    eligible if published reports show that >50% of that tumor type is GD2-positive by
    immunohistochemistry. (Note: Tissues must be fresh/frozen as fixed, paraffin-embedded
    specimens are unsuitable for anti-GD2 immunostaining). Tumors known to be GD2-
    positive by this criteria do not need immunostaining. These include: Melanoma (>50%),
    Desmoplastic small round cell tumors (70%), Osteosarcoma (88%) and Soft tissue
    sarcomas including liposarcoma, fibrosarcoma, malignant fibrous histiocytoma,
    leiomyosarcoma, and spindle cell sarcoma (93%).

    - Patients must have either (1) refractory or relapsed high-risk NB (including
    MYCN-amplified stage 2/3/4/4S of any age and MYCN-nonamplified stage 4 in patients
    greater than 18 months of age)resistant to standard therapy*, or (2) refractory or
    relapsed GD2-positive tumor after receiving available life-prolonging therapies.

    *For NB, standard therapy generally includes 5-8 cycles of high dose induction
    chemotherapy followed by resection of gross residual tumor, with or without
    myeloablative chemotherapy with peripheral blood stem cell rescue and radiation
    therapy to the primary site. There are also salvage chemotherapy regimens for
    residual disease after standard induction therapy or for relapsed NB. Some examples
    of these chemotherapy combinations are: high-dose cyclophosphamide, topotecan and
    vincristine; high-dose cyclophosphamide, irinotecan and vincristine; irinotecan and
    temozolomide; or ifosfamide, carboplatin and etoposide.

    - Patients must be older than 1 year of age.

    - Prior treatment with murine 3F8 is allowed. Patients with prior m3F8, hu3F8, ch14.18
    or hu14.18 treatment must have HAHA antibody titer less than or = to 1300 Elisa
    units/ml

    - White blood cell count 1000/ul

    - Absolute neutrophil count 500/ul

    - Absolute lymphocyte count 500/ul

    - Platelet count 25,000/ul

    - No chemotherapy or immunotherapy for a minimum of three weeks prior to study
    enrollment

    - Women of child-bearing potential must be willing to practice an effective method of
    birth control while on treatment

    - Signed informed consent indicating awareness of the investigational nature of this
    program.

    Exclusion Criteria:

    - Existing major organ dysfunction > grade 2, with the exception of hearing loss and
    hematologic toxicity (defined as suppression of all subtypes of WBCs, RBCs, and
    platelets).

    - Hematologic and primary CNS malignancies

    - Active life-threatening infection.

    - Pregnant women or women who are breast-feeding.

    - Inability to comply with protocol requirements.

    Minimum Eligible Age: 13 Months

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    maximum tolerated dosage

    Secondary Outcome Measures

    pharmacokinetics

    anti-tumor activity

    biologic correlates with hu3F8 dose

    quantification of pain

    Trial Keywords

    INTERLEUKIN 2

    MAB 3F8

    GD2-positive tumor

    12-116