Trial Search Results

Interleukin-12 and Interleukin-2 in Treating Patients With Refractory or Recurrent Neuroblastoma

Phase I trial to compare the effectiveness of interleukin-12 with or without interleukin-2 in treating young patients who have refractory or recurrent neuroblastoma. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining interleukin-2 with interleukin-12 may kill more tumor cells.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

National Cancer Institute (NCI)


  • Biological: recombinant interleukin-12
  • Biological: aldesleukin


Phase 1


Inclusion Criteria:

   - Diagnosis of neuroblastoma

      - Histologically confirmed disease AND/OR disease defined by tumor cells in the
      bone marrow and elevated urinary catecholamine metabolites

   - Persistent and/or refractory disease, with at least 1 of the following:

      - Biopsy-proven residual disease at least 12 weeks after myeloablative therapy

      - Progressive disease after nonmyeloablative or myeloablative therapy

   - Recurrent disease, evidenced by any of the following:

      - Biopsy-proven recurrent soft tissue disease

      - Metaiodobenzylguanidine (MIBG)-positive lesions visible on any other imaging
      modality or repeat MIBG obtained 2-4 weeks or more apart

      - Histologically confirmed bone marrow disease

      - Progressive or stable disease after at least 1 prior standard salvage regime

   - No clinically significant pleural effusion

   - ECOG 0-1

   - Life expectancy >= 12 weeks

   - Hepatitis A antibody negative

   - Hepatitis B surface antigen negative

      - Positive hepatitis B titer allowed if patient has been immunized and has no
      history of disease

   - Hepatitis C virus negative

   - No history of congenital or acquired coagulation disorder

   - Cardiac function normal by ECG

   - No dyspnea at rest

   - No exercise intolerance

   - Oxygen saturation at least 94% by pulse oximetry

   - DLCO greater than 60% of predicted

   - FEV1 greater than 70% of predicted

   - Negative pregnancy test

   - Skull-based bony lesions without space-occupying intracranial extension are allowed

   - No prior or concurrent intracranial metastatic disease to the brain parenchyma

   - Not pregnant or nursing

   - Fertile patients must use effective barrier contraception during and for at least 2
   months after study

   - No prior hematologic malignancy (including leukemia or lymphoma)

   - No history of malignant hyperthermia

   - No prior or concurrent autoimmune disease

   - No positive direct Coombs testing

   - No history of ongoing or intermittent bowel obstruction

   - No active infection or other significant systemic illness

   - More than 2 weeks since prior fenretinide

   - More than 2 weeks since prior 13-cis-retinoic acid

   - More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)

   - More than 2 weeks since prior interferons or interleukins

   - More than 2 weeks since prior cytokine-fusion proteins

   - More than 2 weeks since prior IV immunoglobulin (IVIG)

   - No prior interleukin-12

   - No concurrent cytokines

   - No concurrent fenretinide

   - No concurrent 13-cis-retinoic acid

   - No other concurrent immunomodulators, including:

      - G-CSF and GM-CSF

      - Interferons

      - Other interleukins

      - IVIG

   - More than 4 weeks since prior chemotherapy

   - No other unstable medical condition or critical illness that would preclude study

   - More than 12 weeks since prior myeloablative chemotherapy followed by autologous stem
   cell transplantation:

No prior myeloablative chemotherapy followed by allogeneic bone marrow transplantation

   - More than 2 weeks since prior growth hormones

   - More than 4 weeks since prior systemic corticosteroids

   - More than 2 weeks since prior non-corticosteroid hormonal therapy (including oral
   birth control pills)

   - No concurrent hormonal therapy (including oral birth control pills)

   - No concurrent growth hormones

   - No concurrent systemic corticosteroids, except for use in life-threatening

   - More than 4 weeks since prior radiotherapy

   - No prior solid organ transplantation

   - More than 4 weeks since prior investigational agents

   - No other concurrent investigational agents

   - No prior enrollment on COG-A3973, unless disease has progressed

   - No history of hemolytic anemia

   - Absolute neutrophil count at least 1,500/mm^3 [Note: Independent of growth factor or
   transfusion support]

   - Platelet count at least 75,000/mm^3 [Note: Independent of growth factor or transfusion

   - AST and ALT less than 2.5 times upper limit of normal

   - Bilirubin less than 2.0 mg/dL

   - Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min OR
   creatinine normal

   - HIV negative

   - Ejection fraction at least 50% by echocardiogram or MUGA OR Fractional shortening at
   least 30% by echocardiogram

   - No congestive heart failure

   - No uncontrolled cardiac arrhythmia

Ages Eligible for Study

3 Years - 21 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Judy Hallagan
Not Recruiting