Interleukin-12 In Treating Patients With Refractory Advanced-Stage Ovarian Cancer Or Abdominal Cancer

Study Overview

Interleukin-12 in Treating Patients With Refractory Advanced-Stage Ovarian Cancer or Abdominal Cancer

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.

OBJECTIVES: I. Assess the safety and maximum tolerated dose of recombinant human interleukin-12 (rhIL-12) administered by intraperitoneal infusion in patients with chemotherapy refractory advanced ovarian cancer and other diffuse abdominal carcinomatosis. II. Determine the immunopharmacologic profile of rhIL-12 in this patient population. III. Evaluate the biologic response in selected patients to rhIL-12 administered through intraperitoneal infusions. OUTLINE: This is a dose escalation, multicenter study. 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. All patients are followed for survival.

Cancer

BIOLOGICAL: recombinant interleukin-12

NCI-2012-02272
PCI-98-031
PCI-MWH-97-039
NCI-T97-0031
CDR0000066467 (REGISTRY Identifier) (REGISTRY: PDQ (Physician Data Query))

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 1999-11-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-02-06
First Submitted that Met QC Criteria 2004-05-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-02-07
First Posted (ESTIMATED) 2004-05-20	Results First Posted N/A	Last Verified 2007-04

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm I 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 rec	BIOLOGICAL: recombinant interleukin-12

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm I

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 rec

BIOLOGICAL: recombinant interleukin-12

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Robert P. Edwards, MD, University of Pittsburgh

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record