A Phase 1 Study of ABI-009 (NAB-RAPAMYCIN) in Pediatric Patients With Recurrent or Refractory Solid Tumors, Including CNS Tumors as a Single Agent and in Combination With Temozolomide and Irinotecan
This phase I trial studies the side effects and best dose of nanoparticle albumin-bound rapamycin when given together with temozolomide and irinotecan hydrochloride in treating pediatric patients with solid tumors that have come back after treatment and a period of time during which the tumor could not be detected or has not responded to treatment. Nanoparticle albumin-bound rapamycin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as temozolomide and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nanoparticle albumin-bound rapamycin, temozolomide, and irinotecan hydrochloride may cause the cancer to stop growing or shrink for a period of time and may lessen the symptoms that are caused by the cancer.
• Patients must have a body surface area (BSA) of \>= 0.2 m\^2 at the time of study enrollment
• Patients with recurrent or refractory solid tumors, including CNS tumors, are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)
• Patients must have either measurable or evaluable disease
• Patient's current disease state must be one for which there is no known curative therapy
• Karnofsky \>= 50% for patients \> 16 years of age and Lansky \>= 50 for patients =\< 16 years of age
‣ Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
• Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately
• Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment
‣ \>= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
• Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count \[ANC\] counts): \>= 7 days after the last dose of agent; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment
• Antibodies: \>= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =\< 1
• Corticosteroids: If used to modify immune adverse events related to prior therapy, \>= 14 days must have elapsed since last dose of corticosteroid
• Hematopoietic growth factors: \>= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator
• Interleukins, interferons and cytokines (other than hematopoietic growth factors): \>= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
• Stem cell infusions (with or without total body irradiation \[TBI\]):
‣ Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: \>= 84 days after infusion, and no evidence of graft-versus-host disease (GVHD)
⁃ Autologous stem cell infusion including boost infusion: \>= 42 days
• Cellular therapy: \>= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer \[NK\] cells, dendritic cells, etc.)
• X ray (XRT)/external beam irradiation including protons: \>= 14 days after local XRT; \>= 150 days after TBI, craniospinal XRT or if radiation to \>= 50% of the pelvis; \>= 42 days if other substantial bone marrow (BM) radiation
• Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131 iodine metaiodobenzylguanidine \[131I-MIBG\]): \>= 42 days after systemically administered radiopharmaceutical therapy
• Irinotecan, temozolomide and mammalian target of rapamycin (mTOR) inhibitor exposure:
‣ Patients who have received prior single agent therapy with irinotecan, temozolomide, or an mTOR inhibitor, excluding ABI-009, are eligible
⁃ Patients who have received prior therapy with ABI-009 are not eligible
⁃ Patients who have previously received irinotecan and temozolomide in combination without progressive disease while on therapy are eligible
⁃ Patients who have previously received irinotecan and temozolomide in combination and had significant toxicity with these two drugs are not eligible
⁃ Patients who have received prior therapy with all three agents in combination (i.e. irinotecan, temozolomide, and an mTOR inhibitor) are not eligible
• Adequate Bone Marrow Function Defined as:
• For patients with solid tumors without known bone marrow involvement (no older than 7 days at the start of therapy):
‣ Peripheral absolute neutrophil count (ANC) \>= 1000/mm\^3
⁃ Platelet count \>= 100,000/mm\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
⁃ Hemoglobin \>= 8.0 g/dl at baseline (may receive red blood cell \[RBC\] transfusions)
• Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 ml/min/1.73 m\^2 or a serum creatinine based on age/gender as follows (no older than 7 days at the start of therapy):
‣ Age: maximum serum creatinine (mg/dL)
⁃ 1 to \< 2 years: 0.6 (male and female)
⁃ 13 to \< 16 years: 1.5 (male), 1.4 (female)
⁃ \>= 16 years: 1.7 (male), 1.4 (female)
• Bilirubin (sum of conjugated + unconjugated) =\< 1.5 x upper limit of normal (ULN) for age (no older than 7 days at the start of therapy)
• Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 3 x ULN = 135 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L (no older than 7 days at the start of therapy)
• Serum albumin \>= 2 g/dL (no older than 7 days at the start of therapy)
• Pulse oximetry \> 94% on room air if there is clinical indication for determination (e.g. dyspnea at rest)
• Patients with seizure disorder may be enrolled if on non-enzyme inducing anticonvulsants and well controlled
• Nervous system disorders (National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 5.0) resulting from prior therapy must be =\< grade 2 with the exception of decreased tendon reflex (DTR); any grade of DTR is eligible
• Serum triglyceride level =\< 300 mg/dL (no older than 7 days at the start of therapy)
• Serum total cholesterol level =\< 300 mg/dL (no older than 7 days at the start of therapy)
• Random or fasting blood glucose =\< the upper normal limits for age; if the initial blood glucose is a random sample that is outside of the normal limits, then follow-up fasting blood glucose can be obtained and must be =\< the upper normal limits for age (no older than 7 days at the start of therapy)
• International normalized ratio (INR) =\< 1.5 (no older than 7 days at the start of therapy)
• Not currently receiving anticoagulation therapy
• All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
• Tissue blocks or slides must be sent for all patients; if tissue blocks or slides are unavailable, the study chair must be notified prior to enrollment