Completed

A Phase I Trial of Herceptin and Interleukin-12

What is being tested

recombinant interleukin-12

+ ABI-007/carboplatin/trastuzumab

Biological

Who is being recruted

Urogenital Diseases+134

+ Genital Diseases

+ Adenocarcinoma

Over 18 Years

+26 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: August 1999

See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)

Last updated: February 28, 2013

Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1999

Actual date on which the first participant was enrolled.

OBJECTIVES: I. 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. V. 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.

NCT00004074

Principal SponsorNational Cancer Institute (NCI)

Last updated: February 28, 2013

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdenocarcinomaAdenocarcinoma, PapillaryAdenomaAdnexal DiseasesAdrenal Cortex DiseasesAdrenal Cortex NeoplasmsAdrenal Gland DiseasesAdrenal Gland NeoplasmsAnus DiseasesBile Duct DiseasesBiliary Tract DiseasesBiliary Tract NeoplasmsUrinary Bladder DiseasesBreast DiseasesBronchial NeoplasmsCarcinomaCarcinoma, BronchogenicCarcinoma, Squamous CellCecal DiseasesCecal NeoplasmsUterine Cervical DiseasesColonic DiseasesDigestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsEsophageal DiseasesFallopian Tube DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGallbladder DiseasesGastrointestinal DiseasesGastrointestinal NeoplasmsGenital Diseases, FemaleGenital Diseases, MaleGenital Neoplasms, FemaleGenital Neoplasms, MaleGonadal DisordersHead and Neck NeoplasmsIntestinal DiseasesIntestinal NeoplasmsAdenoma, Islet CellKidney DiseasesKidney NeoplasmsLiver DiseasesLiver NeoplasmsLung DiseasesLung NeoplasmsStomatognathic DiseasesMouth DiseasesMouth NeoplasmsNeoplasm MetastasisNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeoplastic ProcessesOvarian DiseasesOvarian NeoplasmsPancreatic DiseasesParathyroid DiseasesPathologic ProcessesPleural DiseasesPleural EffusionPleural NeoplasmsProstatic DiseasesRectal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsSalivary Gland DiseasesSkin DiseasesStomach DiseasesPathological Conditions, Signs and SymptomsTesticular DiseasesThoracic NeoplasmsThyroid DiseasesUrethral DiseasesUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsUterine DiseasesUterine NeoplasmsVaginal DiseasesVulvar DiseasesColorectal NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsCarcinoma, NeuroendocrineNeoplasms, Ductal, Lobular, and MedullaryNeuroendocrine TumorsFemale Urogenital DiseasesMale Urogenital DiseasesSquamous Cell Carcinoma of Head and NeckCarcinoma, Ovarian EpithelialThyroid Cancer, PapillaryAnus NeoplasmsAppendiceal NeoplasmsBile Duct NeoplasmsUrinary Bladder NeoplasmsBreast NeoplasmsCarcinoma, Non-Small-Cell LungCarcinoma, Renal CellUterine Cervical NeoplasmsColonic NeoplasmsVipomaEsophageal NeoplasmsFallopian Tube NeoplasmsGallbladder NeoplasmsGlucagonomaCarcinoma, HepatocellularInsulinomaNeoplasms, Unknown PrimaryPancreatic NeoplasmsParathyroid NeoplasmsProstatic NeoplasmsRectal NeoplasmsSalivary Gland NeoplasmsSomatostatinomaStomach NeoplasmsTesticular NeoplasmsThyroid NeoplasmsUrethral NeoplasmsVaginal NeoplasmsVulvar NeoplasmsGastrinomaPleural Effusion, MalignantEndometrial NeoplasmsAdenocarcinoma, FollicularAdrenocortical CarcinomaCarcinoma, Islet CellCarcinoma, MedullaryBreast Neoplasms, MaleInflammatory Breast NeoplasmsThyroid Carcinoma, Anaplastic

Criteria

11 inclusion criteria required to participate

The patient must have failed standard curative and/or palliative therapies for their disease

Patients must have measurable or evaluable disease

No concurrent malignancy other than non-melanoma skin carcinoma

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

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15 exclusion criteria prevent from participating

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

Concurrent use of systemic corticosteroids

Serious concurrent infection requiring intravenous antibiotic therapy

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Ohio State University Medical Center

Columbus, United StatesOpen Ohio State University Medical Center in Google Maps

CompletedOne Study Center