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Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00005604

Interleukin-12 Plus Interleukin-2 in Treating Patients With Advanced Solid Tumors

A Phase 1 study testing recombinant interleukin-12, aldesleukin and laboratory biomarker analysis in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase I trial to study the effectiveness of interleukin-12 plus interleukin-2 in treating patients who have advanced solid tumors. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
recombinant interleukin-12, aldesleukin and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
Mar 2000to Jul 2003
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have a histologically confirmed solid tumor malignancy which is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; patients with hematologic malignancies will be excluded
  • Patients must have advanced measurable or evaluable disease which is clearly progressive
  • Patients must be ambulatory with good performance status (ECOG PS 0 or 1; Karnofsky PS 100-80%) and have an anticipated survival of at least 3 months
  • Women of child bearing potential must have a negative pregnancy test and will be expected to use proven contraceptive methods while on protocol therapy; women who are breast-feeding are excluded from this study
  • WBC > 4000/mm^3
  • ANC > 1500/mm^3
Show all 25Show fewer
  • Platelet count > 100,000/mm^3
  • Bilirubin < 1.5 mg/dl
  • SGOT, SGPT < 2 x normal
  • Creatinine < 1.5 mg/dl or calculated creatinine clearance >= 60 ml/min
  • No evidence of congestive heart failure, symptoms of coronary artery disease, serious cardiac arrhythmias, or evidence of prior myocardial infarction on EKG
  • No evidence of active infection which requires antibiotic therapy or history of treatment with IV antibiotics for a documented infection within 2 weeks of beginning treatment
  • Patients must have recovered from the toxicity of prior therapy and have clearly progressive disease
  • CHEMO, HORMONAL, AND RADIOTHERAPY There is a limit of two prior chemotherapy regimens which patients may have received; (patients who have received extensive prior cytotoxic therapy may no longer have adequate organ function and may not be eligible); at least 4 weeks must have elapsed from the end of previous chemotherapy, hormonal therapy, or radiotherapy (six weeks for nitrosoureas or mitomycin); concurrent chemotherapy, hormonal therapy or radiotherapy is not permitted; patients on steroids, including replacement therapy, will be excluded from the study
  • BIOLOGICAL RESPONSE MODIFIERS No more than 2 prior BRM treatment regimens are permitted; prior immunotherapy should have been completed at least 4 weeks prior to beginning treatment on this protocol; prior therapy will IL-2 or rhIL-12 is allowable if >= 6 months have elapsed since the end of IL-2 treatment or if >= 12 months have elapsed since rhIL-12 therapy
  • The patient must give signed informed consent prior to the initiation of therapy; patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with therapy
  • Patients with the following problems will be considered ineligible:
  • Organ allografts
  • Brain metastases
  • Seizure disorders
  • Patients known to be HIV positive are excluded based on the potential harm these agents may have on their underling immune function and the unknown effects of combination therapy with IL-12 and IL-2 on HIV viral replication; in addition, HIV infection, through its documented deleterious effects on lymphocyte number and function, may impair the patient's ability to respond to this form of cytokine-based immunotherapy
  • Any medical condition likely to require use of corticosteroids during IL-12 therapy
  • Autoimmune or rheumatologic disease
  • Active (clinical or subclinical) hepatitis B or hepatitis C infection
  • Any significant medical disease other than the malignancy felt by the investigator to place the patient at greater risk for developing a life-threatening toxicity from the therapy

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Phase I Trial of Twice Weekly IV IL-12 Plus Low-Dose Subcutaneous IL-2 in Patients With Advanced Malignancies

Phase I trial to study the effectiveness of interleukin-12 plus interleukin-2 in treating patients who have advanced solid tumors. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining the two drugs may kill more cancer cells

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the toxicity profile and MTD of low-dose SC IL-2 administered in conjunction with BIW regimen of IV rhIL-12.

II. To determine the antitumor effects of combination therapy with IV rhIL-12 and SC IL-2.

III. To determine the impact low-dose SC IL-2 has on the magnitude and duration of in vivo immune activation induced by a BIW schedule of IV rhIL-12.

OUTLINE: This is a dose-escalation study.

Patients receive interleukin-12 (IL-12) IV on days 1 and 4 for 6 weeks. Beginning on day 4 of the third week, patients receive interleukin-2 (IL-2) subcutaneously 1 hour before and 20 hours after each dose of IL-12. On subsequent courses, IL-2 and IL-12 are administered on days 1 and 4 of each week. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease response may continue treatment until complete response or disease progression.

Cohorts of 3-6 patients receive escalating doses of IL-12 and IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 3 weeks.

Being tested
recombinant interleukin-12, aldesleukin, laboratory biomarker analysis

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 SC

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00005604
Study groupRoleWhat they receive
Treatment (rhIl-12, IL-2)ExperimentalPatients receive interleukin-12 (IL-12) IV on days 1 and 4 for 6 weeks. Beginning on day 4 of the third week, patients receive interleukin-2 (IL-2) subcutaneously 1 hour before and 20 hours after each dose of IL-12. On subsequent courses, IL-2 and IL-12 are administered on days 1 and 4 of each week. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease response may continue treatment until complete response or disease progression.
Receives: Biological: recombinant interleukin-12; Biological: aldesleukin; Other: laboratory biomarker analysis

What is being measured

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

  1. MTD defined as the dose level that is just below the dose on which at least 2 of 6 patients developed a dose-limiting toxicity (DLT) as assessed by CTC version 2.0

    Measured: 6 weeks

Timeline

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

  1. First posted24 Jul 2003 (estimated)
  2. Study startMar 2000
  3. Primary completionJul 2003

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
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005604
Sponsor's protocol ID
NCI-2013-00049
Other IDs
BIDMC #99-1332, CDR0000067723
Status last verified
Jan 2013
First submitted
2 May 2000
Last updated
1 Feb 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing recombinant interleukin-12, aldesleukin and laboratory biomarker analysis in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site 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 25 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: finished, as of the sponsor's last update on 1 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

MTD defined as the dose level that is just below the dose on which at least 2 of 6 patients developed a dose-limiting toxicity (DLT) as assessed by CTC version 2.0 (time frame: 6 weeks). 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 NCT00005604.

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 1 Feb 2013.

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