- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00054405
Interleukin-12 and Interleukin-2 in Treating Patients With Refractory or Recurrent Neuroblastoma
A Phase I Investigation of IL-12 (NSC 672423)/Pulse IL-2 (Aldesleukin) in Children With Persistent and/or Refractory Neuroblastoma (13623)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
I. Define the maximum tolerated dose and dose-limiting toxicity of interleukin-12 with or without interleukin-2 in patients with refractory or recurrent neuroblastoma.
II. Determine, preliminarily, the antitumor effect of interleukin-12 with or without interleukin-2 in these patients.
III. Evaluate the immunoregulatory activity of interleukin-12 with or without interleukin-2 in these patients.
IV. Evaluate the antiangiogenic activity of interleukin-12 with or without interleukin-2 in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are assigned to 1 of 2 treatment cohorts.
COHORT A: Patients receive interleukin-12 (IL-12) IV over 5-15 seconds on days 1, 3, 5, 8, 10, and 12.
COHORT B: Patients receive interleukin-2 (IL-2) IV over 15 minutes twice daily on days 1 and 8 and IL-12 IV as in cohort A.
Treatment in both cohorts repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Some patients may receive additional courses at the discretion of the principal investigator.
Cohorts of 3-6 patients in both cohorts receive escalating doses of IL-2 and IL-12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Once the MTD is determined, an additional cohort of 8 patients receives IL-12 and IL-2 at the MTD.
Patients are followed at 3 weeks.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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California
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Los Angeles, California, Forenede Stater, 90027
- Children's Hospital Los Angeles
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Los Angeles, California, Forenede Stater, 90027-6016
- New Approaches to Neuroblastoma Treatment (NANT)
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Palo Alto, California, Forenede Stater, 94304
- Lucile Packard Children's Hospital Stanford University
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San Francisco, California, Forenede Stater, 94143-0875
- University of California at San Francisco - Comprehensive Cancer Center
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-
Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- AFLAC Cancer Center and Blood Disorders Service
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-
Illinois
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Chicago, Illinois, Forenede Stater, 60614
- Childrens Memorial Hospital
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Riley Hospital for Children
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Children's Hospital Boston
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan University Hospital
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45229
- Cincinnati Children's Hospital Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Children's Hospital of Philadelphia
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Texas
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Houston, Texas, Forenede Stater, 77030
- Texas Children's Hospital
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Washington
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Seattle, Washington, Forenede Stater, 98105
- Seattle Children's Hospital
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53792
- University of Wisconsin Hospital and Clinics
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Treatment (IL-12, aldesleukin)
Cohort A: Patients receive interleukin-12 (IL-12) IV over 5-15 seconds on days 1, 3, 5, 8, 10, and 12. Cohort B: Patients receive interleukin-2 (IL-2) IV over 15 minutes twice daily on days 1 and 8 and IL-12 IV as in cohort A. Treatment in both cohorts repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Some patients may receive additional courses at the discretion of the principal investigator. Cohorts of 3-6 patients in both cohorts receive escalating doses of IL-2 and IL-12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional cohort of 8 patients receives IL-12 and IL-2 at the MTD. |
Givet IV
Andre navne:
Givet IV
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Maximum tolerated dose (MTD) assessed by Common Toxicity Criteria (CTC)
Tidsramme: 28 days
|
28 days
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Overall response assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
Tidsramme: Up to 3 weeks
|
Up to 3 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Jon Wigginton, New Approaches to Neuroblastoma Treatment (NANT)
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer, kirtel og epitel
- Neoplasmer, Neuroepithelial
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Neuroektodermale tumorer, primitive
- Neuroektodermale tumorer, primitive, perifere
- Neuroblastom
- Lægemidlers fysiologiske virkninger
- Anti-infektionsmidler
- Agenter fra det perifere nervesystem
- Antivirale midler
- Anti-HIV-midler
- Anti-retrovirale midler
- Analgetika
- Sensoriske systemagenter
- Analgetika, ikke-narkotisk
- Antineoplastiske midler
- Immunologiske faktorer
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Adjuvanser, immunologiske
- Aldesleukin
- Interleukin-12
- Interleukin-2
Andre undersøgelses-id-numre
- NCI-2009-00024
- P01CA081403 (U.S. NIH-bevilling/kontrakt)
- NANT 2001-01
- CDR0000270447 (Registry Identifier: PDQ (Physician Data Query))
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