Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer

NCT ID: NCT00016289

Last Updated: 2013-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-07-31

Brief Summary

Phase II trial to study the effectiveness of intraperitoneal interleukin-12 in treating patients who have ovarian epithelial cancer or primary peritoneal cancer. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill tumor cells. Giving interleukin-12 directly into the peritoneal cavity may kill cancer cells

Detailed Description

OBJECTIVES:

I. Determine the response rate and progression-free interval in patients with peritoneal carcinomatosis associated with ovarian epithelial cancer or primary peritoneal carcinoma treated with intraperitoneal interleukin-12.

II. Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.

III. Determine peritoneal cavity tumor cell responses, in terms of negative cytology, conversion of aneuploidy to diploidy, and apoptosis as evidence of therapeutic effect, in patients treated with this regimen.

IV. Assess quality of life in patients treated with this regimen. V. Determine the pharmacology and pharmacokinetics of this drug in these patients.

VI. Determine whether this regimen facilitates adaptive or innate immunity in vivo or serum antibody responses to tumor-associated antigens in these patients.

VII. Determine whether this regimen decreases expression of vascular endothelial growth factor, fibroblast growth factor 2, and interleukin-8 as surrogate markers of angiogenesis and whether a decrease in marker expression is associated with clinical activity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive interleukin-12 intraperitoneally once weekly. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease receive 2 additional courses. Quality of life is assessed at baseline; prior to weeks 2, 4, 8, 12, and 16 of treatment; when patients are informed of their disease response; and then 2 weeks later. Patients are followed every 2 months for 1 year and then every 3 months for 1 year.

Conditions

Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer

Study Design

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

Study Groups

Treatment (recombinant interleukin-12)

Patients receive interleukin-12 intraperitoneally once weekly. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease receive 2 additional courses.

Group Type: EXPERIMENTAL

recombinant interleukin-12

Intervention Type: BIOLOGICAL

Given intraperitoneally

Interventions

recombinant interleukin-12

Given intraperitoneally

Intervention Type: BIOLOGICAL

Other Intervention Names

cytotoxic lymphocyte maturation factor; IL-12; interleukin-12; natural killer cell stimulatory factor; Ro 24-7472

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed peritoneal carcinomatosis associated with ovarian epithelial or primary peritoneal epithelial carcinoma

• Surgically documented disease after prior platinum-based chemotherapy with or without surgery
• Minimal residual disease, defined as metastases less than 1 cm in largest diameter
• No significant adhesions or symptoms of obstruction
• No extra-abdominal or parenchymal disease
• No more than 6 weeks since prior primary chemotherapy
• Performance status - Zubrod 0-1
• Absolute granulocyte count greater than 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Lymphocyte count greater than 600/mm^3
• Bilirubin no greater than 1.5 mg/dL
• SGOT or SGPT no greater than 2.5 times upper limit of normal
• Albumin at least 3.0 g/dL
• Hepatitis B and C negative
• Creatinine no greater than 1.5 mg/dL
• No significant cardiac disease
• No significant pulmonary disease
• No overt autoimmune disease
• No other malignancy within the past 10 years except squamous cell carcinoma in situ or basal cell skin cancer
• HIV negative
• Successful placement of peritoneal catheter
• No prior immunotherapy
• See Disease Characteristics
• Recovered from prior chemotherapy
• No concurrent chemotherapy
• No chronic steroid therapy
• No prior radiotherapy
• See Disease Characteristics
• Recovered from prior surgery
• At least 2 weeks since prior laparoscopy
• At least 4 weeks since prior laparotomy

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renato Lenzi

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

MDA-ID-00232

Identifier Type: -

Identifier Source: secondary_id

N01CM17003

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000068619

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02381

Identifier Type: -

Identifier Source: org_study_id