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

Primary Peritoneal Cavity Cancer Clinical Trial

Official title:

Phase II Study of Intraperitoneal Recombinant Human Interleukin-12 (rhIL-12) in Patients With Peritoneal Carcinomatosis (Residual Disease < 1cm) Associated With Ovarian Epithelial Cancer or Primary Peritoneal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00016289
• Other study ID #: NCI-2012-02381
• Secondary ID: MDA-ID-00232N01C
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2001
• Last updated: January 22, 2013
• Start date: July 2001

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer
• Recurrent Ovarian Epithelial Cancer

Intervention

Biological:
• recombinant interleukin-12
Given intraperitoneally

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of remission determined by laparoscopy or laparotomy	Tested using an exact test for a single binomial proportion	Up to 2 years	No
Primary	Toxicity graded using the NCI CTC version 3.0	Evaluated for each dose level and each course of therapy.	Up to 2 years	No
Primary	Progression-free interval		Up to 2 years	No