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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Rate of remission determined by laparoscopy or laparotomy

Outcome Description:

Tested using an exact test for a single binomial proportion

Outcome Time Frame:

Up to 2 years

Safety Issue:

No

Principal Investigator

Renato Lenzi

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02381

NCT ID:

NCT00016289

Start Date:

July 2001

Completion Date:

Related Keywords:

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

Name

Location

M D Anderson Cancer CenterHouston, Texas  77030