Clinical Trials / Research Studies

Clinical Trials / Research Studies

Who can participate?

AGES ELIGIBLE FOR STUDY: 12 Months up to 40 Years

ELIGIBILITY CRITERIA

Inclusion Criteria:

• Age: greater than or equal to 12 months and less than or equal to 40 years.
• Diagnosis: Patients must have had histologic verification of malignancy at original diagnosis or relapse. Eligible diagnoses include:
  
  • Relapsed or refractory solid tumors (excluding primary CNS tumors)
  • Lymphoma in second or greater relapse or with refractory disease
• Disease Evaluation: Patients must have evaluable or measurable disease (patients with evaluable disease must have a lesion that is amenable to radiation as below).
• Patients with stable non-brainstem CNS metastases may be eligible.
• Therapeutic Options: Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.
• Performance Level: Lansky/Karnofsky greater than or equal to 50%.
• Prior Therapy: Patients who have previously received inhibitors of PD-1, PD-L1, CTLA4 or other immune checkpoint inhibitors, regardless of response, are eligible as long as they had not experienced a medically significant immune related adverse event that required treatment with supraphysiologic steroids or other immunomodulatory drug.
• Patients must have recovered from the acute toxic effects of all prior anti-cancer chemotherapy and meet the following:
  
  • Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea).
  • Hematopoietic growth factors: At least 21 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor.
  • Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent.
  • Immunotherapy: At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines.
  • Monoclonal antibodies: At least 4 weeks after the last dose of a monoclonal antibody.
  • XRT: At least 14 days after local palliative XRT (limited field); At least 150 days must have elapsed if prior TBI, craniospinal XRT or radiation treatment resulting in greater than or equal to 50% of the pelvis receiving greater than or equal to 10 Gy.
  • Stem Cell Infusion without TBI: At least 84 days must have elapsed after autologous stem cell transplant or stem cell infusion. Patients having received allogeneic stem cells are not eligible.
• Adequate Bone Marrow Function Defined as:
  
  • Peripheral absolute neutrophil count (ANC) greater than or equal to 750/mm3
  • Platelet count greater than or equal to 75,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
  • Hemoglobin greater than or equal to 8 (transfusions allowed)
  • Patients with known bone marrow involvement will be eligible for the study provided that they have a platelet count of greater than or equal to 50,000/mm3 (transfusion independent, defined as not receiving platelet transfusion for at least 7 days prior to enrollment).
• Adequate Renal Function Defined as:
  
  • Creatinine clearance, cystatin C based GFR, or radioisotope GFR greater than or equal to 70ml/min/1.73 m2 or a serum creatinine based on protocol requirements.
• Adequate Liver Function Defined as:
  
  • Direct bilirubin less than or equal to 1.5 x upper limit of normal (ULN) for age
  • SGPT (ALT) less than or equal to 3.0 x upper limit of normal (ULN). For patients with known liver metastases or primary tumor, SGPT (ALT) less than or equal to 5 x upper limit of normal (ULN) may be accepted. For the purposes of this study, the ULN of SGPT is 45 U/L.
• Adequate Cardiac Function Defined as:
  
  • Ejection fraction of greater than or equal to 50% by echocardiogram (3D if available) or cardiac MRI.
  • QTC less than or equal to 480 msec.
• Adequate Pulmonary Function Defined as:
  
  • Pulse oximetry greater than 94% on room air and no dyspnea at rest.
• Radiation Considerations:
  
  • Patients must have at least one non-CNS lesion amenable to radiation as defined in the protocol and at the discretion of the PIs.
  • Patients with previously irradiated sites of disease may be considered eligible if potential index site lesions meet the following: There has been documented progression at that site (by RECIST or for neuroblastoma patients enrolled with evaluable disease, persistent MIBG avidity), and Re-irradiation would not expose the patient to a substantial increase in toxicity (as determined by consultation with co-principal investigator or designee and treating oncologist).

Exclusion Criteria:

• Patients with primary CNS tumors, brainstem metastases, and/or carcinomatous meningitis are not eligible.
• Pregnant or breast-feeding women will not be entered on this study.
• Corticosteroids and other immunosuppressive therapy: Patients requiring systemic corticosteroids or other immunosuppressive medication within 7 days prior to enrollment are not eligible with the exception of physiologic replacement doses of corticosteroids.
• Patients who are currently receiving another investigational drug are not eligible.
• Patients who are currently receiving other anti-cancer agents are not eligible.
• Patients with a history of an autoimmune disorder are not eligible. Asymptomatic laboratory abnormalities (e.g. ANA, rheumatoid factor) will not render a patient ineligible in the absence of a diagnosis of an autoimmune disorder.
• Patients with known hepatitis B (HBsAg reactive) or C (HCV RNA -qualitative is detected) are excluded.
• Patients with HIV are excluded if they have detectable viral loads or CD4 count is below 400 or they are not compliant with antiretroviral agents.
• Patients who have an uncontrolled infection are not eligible.
• Patients with immunodeficiency syndromes are not eligible.
• Patients with a history of clinically significant cardiac disease are not eligible.
• Patients with ongoing interstitial lung disease or pneumonitis are not eligible.
• Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction).
• Patients who have received a live vaccine less than or equal to 30 days prior to enrollment are ineligible.
• Patients who have received a prior solid organ transplant at any time, or allogeneic bone marrow transplantation within the past 5 years (or have signs or symptoms of GVHD) are not eligible.
• Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.