NCT00004074

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
3.9 years until next milestone

First Posted

Study publicly available on registry

October 29, 2003

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Last Updated

February 28, 2013

Status Verified

February 1, 2013

Enrollment Period

9.5 years

First QC Date

December 10, 1999

Last Update Submit

February 27, 2013

Conditions

Advanced Adult Primary Liver CancerAnaplastic Thyroid CancerBone MetastasesCarcinoma of the AppendixDistal Urethral CancerFallopian Tube CancerGastrinomaGlucagonomaInflammatory Breast CancerInsulinomaLiver MetastasesLocalized Unresectable Adult Primary Liver CancerLung MetastasesMale Breast CancerMalignant Pericardial EffusionMalignant Pleural EffusionMetastatic Gastrointestinal Carcinoid TumorMetastatic Parathyroid CancerMetastatic Transitional Cell Cancer of the Renal Pelvis and UreterNewly Diagnosed Carcinoma of Unknown PrimaryOccult Non-small Cell Lung CancerPancreatic Polypeptide TumorPrimary Peritoneal Cavity CancerProximal Urethral CancerPulmonary Carcinoid TumorRecurrent Adenoid Cystic Carcinoma of the Oral CavityRecurrent Adrenocortical CarcinomaRecurrent Adult Primary Liver CancerRecurrent Anal CancerRecurrent Bladder CancerRecurrent Breast CancerRecurrent Carcinoma of Unknown PrimaryRecurrent Cervical CancerRecurrent Colon CancerRecurrent Endometrial CarcinomaRecurrent Esophageal CancerRecurrent Extrahepatic Bile Duct CancerRecurrent Gallbladder CancerRecurrent Gastric CancerRecurrent Gastrointestinal Carcinoid TumorRecurrent Islet Cell CarcinomaRecurrent Malignant Testicular Germ Cell TumorRecurrent Mucoepidermoid Carcinoma of the Oral CavityRecurrent Non-small Cell Lung CancerRecurrent Ovarian Epithelial CancerRecurrent Pancreatic CancerRecurrent Parathyroid CancerRecurrent Prostate CancerRecurrent Rectal CancerRecurrent Renal Cell CancerRecurrent Salivary Gland CancerRecurrent Small Intestine CancerRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Thyroid CancerRecurrent Transitional Cell Cancer of the Renal Pelvis and UreterRecurrent Urethral CancerRecurrent Vaginal CancerRecurrent Vulvar CancerSkin MetastasesSmall Intestine AdenocarcinomaSomatostatinomaStage III Adenoid Cystic Carcinoma of the Oral CavityStage III Adrenocortical CarcinomaStage III Bladder CancerStage III Cervical CancerStage III Colon CancerStage III Endometrial CarcinomaStage III Esophageal CancerStage III Follicular Thyroid CancerStage III Gastric CancerStage III Malignant Testicular Germ Cell TumorStage III Mucoepidermoid Carcinoma of the Oral CavityStage III Ovarian Epithelial CancerStage III Pancreatic CancerStage III Papillary Thyroid CancerStage III Prostate CancerStage III Rectal CancerStage III Renal Cell CancerStage III Salivary Gland CancerStage III Squamous Cell Carcinoma of the LarynxStage III Squamous Cell Carcinoma of the Lip and Oral CavityStage III Squamous Cell Carcinoma of the NasopharynxStage III Squamous Cell Carcinoma of the OropharynxStage III Vaginal CancerStage III Vulvar CancerStage IIIA Anal CancerStage IIIA Breast CancerStage IIIA Non-small Cell Lung CancerStage IIIB Anal CancerStage IIIB Breast CancerStage IIIB Non-small Cell Lung CancerStage IV Adenoid Cystic Carcinoma of the Oral CavityStage IV Adrenocortical CarcinomaStage IV Anal CancerStage IV Bladder CancerStage IV Breast CancerStage IV Colon CancerStage IV Endometrial CarcinomaStage IV Esophageal CancerStage IV Follicular Thyroid CancerStage IV Gastric CancerStage IV Mucoepidermoid Carcinoma of the Oral CavityStage IV Non-small Cell Lung CancerStage IV Ovarian Epithelial CancerStage IV Pancreatic CancerStage IV Papillary Thyroid CancerStage IV Prostate CancerStage IV Rectal CancerStage IV Renal Cell CancerStage IV Salivary Gland CancerStage IV Squamous Cell Carcinoma of the LarynxStage IV Squamous Cell Carcinoma of the Lip and Oral CavityStage IV Squamous Cell Carcinoma of the NasopharynxStage IV Squamous Cell Carcinoma of the OropharynxStage IVA Cervical CancerStage IVA Vaginal CancerStage IVB Cervical CancerStage IVB Vaginal CancerStage IVB Vulvar CancerThyroid Gland Medullary CarcinomaUnresectable Extrahepatic Bile Duct CancerUnresectable Gallbladder CancerUrethral Cancer Associated With Invasive Bladder CancerWDHA Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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)

    Up to 52 weeks

Study Arms (1)

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.

Biological: recombinant interleukin-12Biological: ABI-007/carboplatin/trastuzumab

Interventions

recombinant interleukin-12BIOLOGICAL

Given IV

Also known as: cytotoxic lymphocyte maturation factor, IL-12, interleukin-12, natural killer cell stimulatory factor, Ro 24-7472
Treatment (IL12 and trastuzumab)
ABI-007/carboplatin/trastuzumabBIOLOGICAL

Given IV

Treatment (IL12 and trastuzumab)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Thyroid Carcinoma, AnaplasticAppendiceal NeoplasmsFallopian Tube NeoplasmsGastrinomaGlucagonomaInflammatory Breast NeoplasmsInsulinomaBreast Neoplasms, MalePleural Effusion, MalignantParathyroid NeoplasmsAdrenocortical CarcinomaCarcinoma, HepatocellularAnus NeoplasmsUrinary Bladder NeoplasmsBreast NeoplasmsNeoplasms, Unknown PrimaryUterine Cervical NeoplasmsColonic NeoplasmsEndometrial NeoplasmsEsophageal NeoplasmsBile Duct NeoplasmsGallbladder NeoplasmsStomach NeoplasmsCarcinoma, Islet CellTesticular NeoplasmsCarcinoma, Non-Small-Cell LungCarcinoma, Ovarian EpithelialPancreatic NeoplasmsProstatic NeoplasmsRectal NeoplasmsCarcinoma, Renal CellSalivary Gland NeoplasmsSquamous Cell Carcinoma of Head and NeckThyroid NeoplasmsUrethral NeoplasmsVaginal NeoplasmsVulvar NeoplasmsSomatostatinomaAdenocarcinoma, FollicularThyroid Cancer, PapillaryCarcinoma, MedullaryVipoma

Interventions

Interleukin-12 Subunit p35Interleukin-12Trastuzumab

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsCecal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesCecal DiseasesIntestinal DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesAdenocarcinomaEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenoma, Islet CellAdenomaPleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsPleural EffusionPleural DiseasesRespiratory Tract DiseasesHead and Neck NeoplasmsParathyroid DiseasesAdrenal Cortex NeoplasmsAdrenal Gland NeoplasmsAdrenal Cortex DiseasesAdrenal Gland DiseasesLiver NeoplasmsLiver DiseasesColorectal NeoplasmsAnus DiseasesRectal DiseasesUrologic NeoplasmsUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsUterine NeoplasmsUterine Cervical DiseasesUterine DiseasesColonic DiseasesEsophageal DiseasesBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract DiseasesGallbladder DiseasesStomach DiseasesGenital Neoplasms, MaleGenital Diseases, MaleTesticular DiseasesGonadal DisordersCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsLung DiseasesOvarian NeoplasmsOvarian DiseasesProstatic DiseasesKidney NeoplasmsKidney DiseasesMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesCarcinoma, Squamous CellThyroid DiseasesUrethral DiseasesVaginal DiseasesVulvar DiseasesCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalAdenocarcinoma, PapillaryNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsSerum GlobulinsGlobulins

Study Officials

  • William Carson

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 1999

First Posted

October 29, 2003

Study Start

August 1, 1999

Primary Completion

February 1, 2009

Last Updated

February 28, 2013

Record last verified: 2013-02

Locations

US(1)