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Recurrent NeuroblastomaPhase 1NCT00054405

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

A Phase 1 study testing recombinant interleukin-12 and aldesleukin in people with Recurrent Neuroblastoma, run by National Cancer Institute (NCI) at 14 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 3 to 21 years
Conditions the study is for
Recurrent Neuroblastoma
What is being tested?
recombinant interleukin-12 and aldesleukin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
14 sitesUnited States
Study dates
Dec 2002to May 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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:
Show all 75Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • University of Michigan University Hospital

    Ann Arbor, Michigan, 48109

  • AFLAC Cancer Center and Blood Disorders Service

    Atlanta, Georgia, 30322

  • Children's Hospital Boston

    Boston, Massachusetts, 02115

  • Childrens Memorial Hospital

    Chicago, Illinois, 60614

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Texas Children's Hospital

    Houston, Texas, 77030

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202

  • New Approaches to Neuroblastoma Treatment (NANT)

    Los Angeles, California, 90027-6016

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Lucile Packard Children's Hospital Stanford University

    Palo Alto, California, 94304

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • University of California at San Francisco - Comprehensive Cancer Center

    San Francisco, California, 94143-0875

  • Seattle Children's Hospital

    Seattle, Washington, 98105

Other trials in United States

About this study

Official title: A Phase I Investigation of IL-12 (NSC 672423)/Pulse IL-2 (Aldesleukin) in Children With Persistent and/or Refractory Neuroblastoma (13623)

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.

Read the detailed description

OBJECTIVES:

  1. 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.

Being tested
recombinant interleukin-12, aldesleukin
Medical subject headings
Neuroblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • recombinant interleukin-12Biological

    Also called cytotoxic lymphocyte maturation factor, IL-12, interleukin-12, natural killer cell stimulatory factor

    Given IV

  • aldesleukinBiological

    Also called IL-2, Proleukin, recombinant human interleukin-2, recombinant interleukin-2

    Given IV

Study groups in NCT00054405
Study groupRoleWhat they receive
Treatment (IL-12, aldesleukin)ExperimentalCohort 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.
Receives: Biological: recombinant interleukin-12; Biological: aldesleukin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD) assessed by Common Toxicity Criteria (CTC)

    Measured: 28 days

Secondary outcomes (1)

  1. Overall response assessed by Response Evaluation Criteria for Solid Tumors (RECIST)

    Measured: Up to 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2003 (estimated)
  2. Study startDec 2002
  3. Primary completionMay 2009

Why it stopped: Administratively complete.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00054405
Sponsor's protocol ID
NCI-2009-00024
Other IDs
NANT 2001-01, CDR0000270447, P01CA081403, CDR0000270447
Status last verified
Apr 2013
First submitted
5 Feb 2003
Last updated
9 Apr 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing recombinant interleukin-12 and aldesleukin in people with Recurrent Neuroblastoma, run by National Cancer Institute (NCI) at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 75 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) assessed by Common Toxicity Criteria (CTC) (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00054405.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2013.

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