NCT00003439

Brief Summary

Phase I trial to study the effectiveness of interleukin-12 in treating patients with refractory ovarian or abdominal cancers. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a persons's white blood cells to kill cancer cells.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for phase_1 cancer

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1998

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2001

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

May 20, 2004

Completed
Last Updated

February 7, 2013

Status Verified

April 1, 2007

Enrollment Period

2.8 years

First QC Date

November 1, 1999

Last Update Submit

February 6, 2013

Conditions

Cancer

Keywords

stage IV colon cancerstage IV gastric cancerrecurrent gastric cancerrecurrent pancreatic cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal cancerstage IV anal cancerrecurrent anal cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial cancermetastatic gastrointestinal carcinoid tumorrecurrent gastrointestinal carcinoid tumoradvanced adult primary liver cancerrecurrent adult primary liver cancerstage IV endometrial carcinomarecurrent endometrial carcinomasmall intestine adenocarcinomaunresectable gallbladder cancerrecurrent gallbladder cancerunresectable extrahepatic bile duct cancerrecurrent extrahepatic bile duct cancerrecurrent small intestine cancerstage IV prostate cancerrecurrent prostate cancerfallopian tube cancerprimary peritoneal cavity cancerstage IV pancreatic cancer

Study Arms (1)

Arm I

EXPERIMENTAL

Cohorts of 3-6 patients each receive escalating doses of intraperitoneal recombinant human interleukin-12 (rhIL-12) administered weekly for 9 weeks. If a patient tolerates rhIL-12 and shows evidence of objective response or stable disease, patient may receive up to 9 additional weeks of treatment. Treatment continues in the absence of unacceptable toxicity or disease progression. Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which no more than 1 of 6 patients experiences dose limiting toxicity.

Biological: recombinant interleukin-12

Interventions

recombinant interleukin-12BIOLOGICAL
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed intraabdominal cancer * Diffuse abdominal carcinomatosis Chemotherapy refractory advanced stage ovarian cancer * Measurable disease * Residual, recurrent, or metastatic disease beyond the scope of standard curative therapy * Extension of disease to sites distant to the peritoneal cavity allowed Retroperitoneal lymphadenopathy allowed as long as there is evaluable intraabdominal disease * No history of progressive brain metastases PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: Karnofsky 70-100% * Hemoglobin greater than 9 g/dL * WBC greater than 3,000/mm3 * Platelet count greater than 100,000/mm3 * Bilirubin less than 2.0 mg/dL * ALT less than 100 U/L * Creatinine clearance greater than 60 mL/min * Normal electrocardiogram * No recent history of cardiac ischemia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Hepatitis B negative * No evidence of clinical immunodeficiency syndromes or immunodeficiency associated diseases * No history of autoimmune disease * No concurrent major illness * No serious infection requiring intravenous antibiotics * No active peptic ulcer disease * Must have free flow of fluid into the peritoneal space * No leakage from the catheter exit site PRIOR CONCURRENT THERAPY: * At least 3 weeks since prior biologic therapy (6 weeks for interleukin-2) * No prior recombinant human interleukin-12 * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) * No concurrent systemic chemotherapy * No concurrent systemic corticosteroids * No prior radiation therapy to the whole abdomen * No concurrent radiotherapy * At least 3 weeks since prior exposure to any investigational drug * No concurrent investigational drug

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

NeoplasmsColonic NeoplasmsStomach NeoplasmsPancreatic NeoplasmsRectal NeoplasmsAnus NeoplasmsCarcinoma, Ovarian EpithelialCarcinoma, HepatocellularEndometrial NeoplasmsGallbladder NeoplasmsBile Duct NeoplasmsProstatic NeoplasmsFallopian Tube Neoplasms

Interventions

Interleukin-12 Subunit p35

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesStomach DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesRectal DiseasesAnus DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeOvarian NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesGonadal DisordersAdenocarcinomaLiver NeoplasmsLiver DiseasesUterine NeoplasmsUterine DiseasesBiliary Tract NeoplasmsBiliary Tract DiseasesGallbladder DiseasesBile Duct DiseasesGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital DiseasesFallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Interleukin-12InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Robert P. Edwards, MD

    University of Pittsburgh

    STUDY CHAIR

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

November 1, 1999

First Posted

May 20, 2004

Study Start

August 1, 1998

Primary Completion

May 1, 2001

Last Updated

February 7, 2013

Record last verified: 2007-04

Locations

US(1)