NCT00028535

Brief Summary

Phase I trial to study the effectiveness of interleukin-12, paclitaxel, and trastuzumab in treating patients who have 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. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining interleukin-12, chemotherapy, and monoclonal antibody therapy may kill more tumor cells.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 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

November 1, 2001

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2002

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

7.3 years

First QC Date

January 4, 2002

Last Update Submit

June 3, 2013

Conditions

Male Breast CancerRecurrent Breast CancerRecurrent Endometrial CarcinomaRecurrent Gastric CancerRecurrent Non-small Cell Lung CancerRecurrent Ovarian Epithelial CancerRecurrent Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • MTD of IL-12, defined as the dose level one level beneath that dose at which 2 or more of 6 patients showed DLT, based on the NCI CTC version 2.0

    Up to 21 days

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15 and paclitaxel IV over 3 hours on day 1 of course 1. Beginning with course 2, patients receive trastuzumab and paclitaxel as in course 1 and interleukin-12 subcutaneously on days 2, 5, 9, 12, 16, and 19. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Biological: trastuzumabDrug: paclitaxelBiological: recombinant interleukin-12

Interventions

trastuzumabBIOLOGICAL

Given IV

Also known as: anti-c-erB-2, Herceptin, MOAB HER2
Arm I
paclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol
Arm I
recombinant interleukin-12BIOLOGICAL

Given SC

Also known as: cytotoxic lymphocyte maturation factor, IL-12, interleukin-12, natural killer cell stimulatory factor, Ro 24-7472
Arm I

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed HER2/neu-overexpressing (2+ or 3+) malignancy by any standardized assay (fluorescence in-situ hybridization allowed)
  • Measurable or evaluable disease
  • Failed standard curative therapy
  • No brain or CNS metastasis
  • Hormone receptor status:
  • Not specified
  • Male or female
  • Performance status - Karnofsky 70-100%
  • At least 6 months
  • Absolute neutrophil count at least 1,500/mm\^3
  • Hemoglobin at least 8 g/dL (transfusion or epoetin alfa allowed)
  • Platelet count at least 100,000/mm\^3
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 3.0 times ULN
  • Hepatitis B surface antigen negative
  • +28 more criteria

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

Breast Neoplasms, MaleBreast NeoplasmsEndometrial NeoplasmsStomach NeoplasmsCarcinoma, Non-Small-Cell LungCarcinoma, Ovarian EpithelialSmall Cell Lung Carcinoma

Interventions

TrastuzumabPaclitaxelTaxesInterleukin-12 Subunit p35Interleukin-12

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesEconomicsHealth Care Economics and OrganizationsInterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesBiological Factors

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

January 4, 2002

First Posted

January 27, 2003

Study Start

November 1, 2001

Primary Completion

February 1, 2009

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

US(1)