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Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
This study has been completed.
Study NCT00016289   Information provided by National Cancer Institute (NCI)
First Received: May 6, 2001   Last Updated: February 6, 2009   History of Changes

May 6, 2001
February 6, 2009
July 2001
 
 
 
Complete list of historical versions of study NCT00016289 on ClinicalTrials.gov Archive Site
 
 
 
Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Phase II Study of Intraperitoneal Recombinant Human Interleukin-12 (rhIL-12) NSC (672423) in Patients With Peritoneal Carcinomatosis (Residual Disease <1cm) Associated With Ovarian Epithelial Cancer

RATIONALE: 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.

PURPOSE: Phase II trial to study the effectiveness of intraperitoneal interleukin-12 in treating patients who have ovarian epithelial cancer cancer or primary peritoneal cancer.

OBJECTIVES:

  • 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.
  • Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.
  • 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.
  • Assess quality of life in patients treated with this regimen.
  • Determine the pharmacology and pharmacokinetics of this drug in these patients.
  • Determine whether this regimen facilitates adaptive or innate immunity in vivo or serum antibody responses to tumor-associated antigens in these patients.
  • 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.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1 year.

Phase II
Interventional
Treatment
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
Biological: recombinant interleukin-12
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • 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 extraabdominal or parenchymal disease
  • No more than 6 weeks since prior primary chemotherapy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute granulocyte count greater than 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Lymphocyte count greater than 600/mm^3

Hepatic:

  • 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

Renal:

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular:

  • No significant cardiac disease

Pulmonary:

  • No significant pulmonary disease

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy

Chemotherapy:

  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • No chronic steroid therapy

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics
  • Recovered from prior surgery
  • At least 2 weeks since prior laparoscopy
  • At least 4 weeks since prior laparotomy
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00016289
 
CDR0000068619, MDA-ID-00232, NCI-2251
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Renato Lenzi, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP