ABOUT THIS STUDY
- Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines
- Patients are required to have an activating ALK aberration in their tumor detected by certified assay (i.e. CLIA in the US.) prior to registration. The report from this test is required to be submitted for eligibility. Patients with at least one of the following genetic features in their tumor will be considered to have an activating ALK aberration:
1. An ALK activating mutation;
2. ALK amplification (> 10 signals of the ALK gene);
3. Presence of any ALK fusion protein that arises from a chromosomal translocation.
- Patients must have high risk neuroblastoma according to COG risk classification at the time of study registration. Patients who were initially considered low or intermediate risk, but then reclassified as high risk are also eligible.
- Patients must have at least ONE of the following: 1) Recurrent/progressive disease at any time prior to study enrollment, 2) Refractory disease, 3) Persistent disease
- Patients must have at least ONE of the following: 1) Bone disease, 2) Any amount of neuroblastoma tumor cells in the bone marrow, 3) At least one soft tissue lesion that meets criteria for a TARGET lesion, 4) At least one non-target soft tissue lesion that is not measurable, but had a biopsy positive for neuroblastoma and/or ganglioneuroblastoma at any time prior to enrollment or is MIBG avid
- Patients must have a Lansky (≤16 years) or Karnofsky (> 16 years) score of at least 50
- Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
- Patients must not have been previously treated with lorlatinib.
- Patients must not have received any of the specified therapies as stated in the protocol in the time period prior to registration
- Patients must not be receiving any other anti-cancer agents or radiotherapy at the time of study entry or while on study.
- Patients must not be receiving other investigational medications (covered under another IND) within 30 days of study entry or while on study.
- Patients must not be receiving chronic systemic corticosteroids at doses greater than physiologic dosing (inhaled corticosteroids acceptable).
- Patient must meet the organ function and system function requirements as stated in the protocol
- Pregnancy, breast feeding, or unwillingness to use effective contraception during the
- Patients who, in the opinion of the investigator, may not be able to comply with the
safety monitoring requirements of the study.
- Patients with disease of any major organ system that would compromise their ability to
- Patients who have received prior allogeneic stem cell transplant
- Patients who are on hemodialysis.
- Patients with an active or uncontrolled infection.
- Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or
- Patient declines participation in NANT 2004-05, the NANT Biology Study
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