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

NCT ID: NCT00003439

Last Updated: 2013-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-08-31

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.

Detailed Description

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.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 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.

Group Type: EXPERIMENTAL

recombinant interleukin-12

Intervention Type: BIOLOGICAL

Interventions

recombinant interleukin-12

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert P. Edwards, MD

Role: STUDY_CHAIR

University of Pittsburgh

Locations

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PCI-98-031

Identifier Type: -

Identifier Source: secondary_id

PCI-MWH-97-039

Identifier Type: -

Identifier Source: secondary_id

NCI-T97-0031

Identifier Type: -

Identifier Source: secondary_id

CDR0000066467

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02272

Identifier Type: -

Identifier Source: org_study_id