Advanced Adult Primary Liver CancerPhase 1NCT00004074

Interleukin-12 and Trastuzumab in Treating Patients With Cancer That Has High Levels of HER2/Neu

A Phase 1 study testing recombinant interleukin-12 and ABI-007/carboplatin/trastuzumab in people with Advanced Adult Primary Liver Cancer and Anaplastic Thyroid Cancer, 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Adult Primary Liver Cancer, Anaplastic Thyroid Cancer, Bone Metastases
What is being tested?: recombinant interleukin-12 and ABI-007/carboplatin/trastuzumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Aug 1999to Feb 2009
Phase: Phase 1

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 proven Her2 overexpressing malignancy as determined by any standardized assay currently in clinical use
Patients must have measurable or evaluable disease
The patient must have failed standard curative and/or palliative therapies for their disease
Life expectancy of at least 6 months
No concurrent malignancy other than non-melanoma skin carcinoma
Adequate hematopoietic, cardiac, renal, and hepatic function

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Calculated creatinine clearance will be used to assess renal function
Karnofsky Performance Status index >= 70%
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation; a woman of childbearing potential is defined as a female who is biologically capable of becoming pregnant
Normal cardiac ejection fraction by echocardiogram or MUGA (i.e., greater than OSU lower limit of normal)
Written signed informed consent; the patient must be aware that his/her disease is neoplastic in nature and willingly consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts

Who cannot join

History of significant peripheral neuropathy or significant central nervous system disease
Brain or central nervous system metastasis at entry
Active or unstable cardiovascular disease or cardiac disease requiring drug or device intervention; history of coronary artery disease or congestive heart failure
Pregnant or nursing women
Surgery, radiotherapy, chemotherapy, or hormonal therapy during the three weeks prior to the initiation of therapy
Exposure to any investigational drug within three weeks prior to the start of dosing

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Concurrent use of systemic corticosteroids
Known seropositive for hepatitis B surface antigen
Known seropositive for HIV antibody
Serious concurrent infection requiring intravenous antibiotic therapy
Clinically significant autoimmune disease (e.g., rheumatoid arthritis)
Clinically significant gastrointestinal bleeding or uncontrolled peptic ulcer disease
History of inflammatory bowel disease
Any other major illness which, in the investigator's judgment, will substantially increase the risk associated with the patient's participation in this study
Prior therapy with Herceptin

Trial locations and contacts

1 site in 1 country.

United States1 site

Ohio State University Medical Center
Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: A Phase I Trial of Herceptin and Interleukin-12

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. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Phase I trial to study the effectiveness of interleukin-12 and trastuzumab in treating patients who have cancer that has high levels of HER2/neu and has not responded to previous therapy

Read the detailed description

OBJECTIVES:

Determine the maximum tolerated dose of interleukin-12 (IL-12) when combined with trastuzumab in patients with HER2-Neu overexpressing malignancies.

II. Determine the safety of this regimen in these patients.

III. Analyze any expression of interferon-inducible genes in tumor tissues of these patients after receiving this regimen.

IV. Characterize natural killer cytokine production in patients treated with this regimen.

Determine serum interferon gamma levels in patients treated with this regimen.

OUTLINE:

This is a dose escalation study of interleukin-12 (IL-12).

Patients receive an initial loading dose of trastuzumab IV over 90 minutes on day 1 of the first week and a maintenance dose of trastuzumab IV over 30-90 minutes on day 1 of each subsequent week. Patients receive IL-12 IV on days 2 and 5 beginning on week 3. Treatment with maintenance trastuzumab and IL-12 repeats weekly for 14 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease continue treatment for up to 38 additional weeks.

Cohorts of 3-6 patients receive escalating doses of IL-12 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 every 3 months for 1 year and then every 6 months thereafter for survival.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 6 months.

Conditions: Advanced Adult Primary Liver Cancer, Anaplastic Thyroid Cancer, Bone Metastases, Carcinoma of the Appendix, Distal Urethral Cancer, Fallopian Tube Cancer
Being tested: recombinant interleukin-12, ABI-007/carboplatin/trastuzumab
Medical subject headings: Thyroid Carcinoma, Anaplastic, Appendiceal Neoplasms, Fallopian Tube Neoplasms, Gastrinoma, Glucagonoma, Inflammatory Breast Neoplasms, Insulinoma, Breast Neoplasms, Male

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
ABI-007/carboplatin/trastuzumabBiological
Given IV

Study groups in NCT00004074
Study group	Role	What they receive
Treatment (IL12 and trastuzumab)	Experimental	Patients receive an initial loading dose of trastuzumab IV over 90 minutes on day 1 of the first week and a maintenance dose of trastuzumab IV over 30-90 minutes on day 1 of each subsequent week. Patients receive IL-12 IV on days 2 and 5 beginning on week 3. Treatment with maintenance trastuzumab and IL-12 repeats weekly for 14 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease continue treatment for up to 38 additional weeks. Receives: Biological: recombinant interleukin-12; Biological: ABI-007/carboplatin/trastuzumab

What is being measured

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

Maximum tolerated dose (MTD) determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 2.0 (CTCAE v2.0)
Measured: Up to 52 weeks

Timeline

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

Aug 1999Feb 2009

First posted29 Oct 2003 (estimated)
Study startAug 1999
Primary completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Adult Primary Liver CancerStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00004074
Sponsor's protocol ID: NCI-2012-01398
Other IDs: 99H0185, U01CA076576, CDR0000067282
Status last verified: Feb 2013
First submitted: 10 Dec 1999
Last updated: 28 Feb 2013
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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