Gene Therapy Clinical Trials

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.

Intervention(s):

  • biological: aldesleukin
  • biological: recombinant interleukin-12

Eligibility


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
   participation

   - 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
   complications

   - 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
   support]

   - 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

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Judy Hallagan
6507248811
Not Recruiting