NCT00003046

Brief Summary

RATIONALE: Interleukin-12 may kill tumor cells by stimulating a person's white blood cells to kill cancer cells. PURPOSE: Phase I trial to study the effectiveness of interleukin-12 in treating patients with cancer in the abdomen.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 1997

Longer than P75 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, 1997

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2001

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

February 19, 2004

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

4.2 years

First QC Date

November 1, 1999

Last Update Submit

July 27, 2012

Conditions

Anal CancerColorectal CancerGallbladder CancerGastric CancerPancreatic Cancer

Keywords

anal cancercarcinoma of the appendixcolorectal cancerextrahepatic bile duct cancergallbladder cancergastric cancergastrointestinal carcinoid tumormalignant mesotheliomapancreatic cancersmall intestine cancerstage IV colon cancerstage IV gastric cancerrecurrent gastric cancerrecurrent pancreatic cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal cancerstage IV anal cancerrecurrent anal cancermetastatic gastrointestinal carcinoid tumorrecurrent gastrointestinal carcinoid tumoradvanced malignant mesotheliomarecurrent malignant mesotheliomasmall intestine adenocarcinomaunresectable gallbladder cancerrecurrent gallbladder cancerunresectable extrahepatic bile duct cancerrecurrent extrahepatic bile duct cancerrecurrent small intestine cancerstage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD) of Intraperitoneal Interleukin-12

    MTD found in absence of unacceptable toxicity or disease progression with each 4 week treatment cycle.

    4 weeks

Study Arms (1)

Interleukin-12

EXPERIMENTAL
Biological: Recombinant Interleukin-12

Interventions

Recombinant Interleukin-12BIOLOGICAL

Intraperitoneal over 30 minutes once weekly for 4 weeks, repeats every 4 weeks for up to 6 courses

Also known as: Intraperitoneal Recombinant Human Interleukin-12, rhIL-12
Interleukin-12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed Mullerian carcinoma (ovarian epithelial or peritoneal carcinoma) (closed to accrual as of 8/23/01) OR Gastrointestinal cancer with abdominal carcinomatosis OR Peritoneal mesothelioma (closed to accrual as of 8/23/01) Must have received an adequate course of any platinum-based chemotherapy regimen for ovarian cancer with evidence of intraabdominal disease Must have received an adequate course of fluorouracil-based treatment for metastatic colon cancer Intact primary gastrointestinal tumor allowed if not at risk of obstruction and/or bleeding Abdominal lesions must be less than 10 cm Extraperitoneal lesions must be less than 2 cm No hepatic disease No clinically significant pleural effusion (controlled by pleurodesis allowed) No brain metastases No significant adhesions or symptoms of obstruction PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL (transfusion allowed) Lymphocyte count at least 800/mm3 Hepatic: See Disease Characteristics Bilirubin no greater than 1.5 mg/dL SGOT or SGPT less than 2.5 times upper limit of normal Albumin at least 3.5 g/dL Hepatitis B and C negative Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No significant heart disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Loss of no more than 10% of body weight over a 4 month period No overt autoimmune disease No active ulcer disease No prior inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) PRIOR CONCURRENT THERAPY: Biologic therapy: No other concurrent immunotherapy Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered No concurrent chemotherapy Endocrine therapy: No chronic steroid therapy Radiotherapy: At least 3 months since prior localized radiotherapy (e.g., pelvic or small field) and recovered No radiotherapy to whole abdomen No concurrent radiotherapy Surgery: Recovered from prior surgery At least 3 weeks since prior major abdominal surgery At least 2 weeks since prior laparoscopy

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 Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related Publications (1)

  • Lenzi R, Kudelka AP, Veschraegen C, et al.: Intraperitoneal (IP) bioimmunologic responses in patients with ovarian and gastrointestinal cancers at a low toxicity dosing schedule of IP recombinant interleukin-12 (rhIL-12). [Abstract] Proc Am Assoc Cancer Res 40: A3778, 573, 1999.

    RESULT

Related Links

MeSH Terms

Conditions

Anus NeoplasmsColorectal NeoplasmsGallbladder NeoplasmsStomach NeoplasmsPancreatic NeoplasmsAppendiceal NeoplasmsBile Duct NeoplasmsMesothelioma, MalignantColonic NeoplasmsRectal Neoplasms

Interventions

Interleukin-12 Subunit p35

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal DiseasesColonic DiseasesBiliary Tract NeoplasmsBiliary Tract DiseasesGallbladder DiseasesStomach DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesCecal NeoplasmsCecal DiseasesBile Duct DiseasesMesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsPleural NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Renato Lenzi, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

February 19, 2004

Study Start

August 1, 1997

Primary Completion

October 1, 2001

Study Completion

October 1, 2001

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations

US(1)