Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	MDA-ID-00232 NCI-2251, NCT00016289, 2251

Objectives

1. 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.
2. Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.
3. 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.
4. Assess quality of life in patients treated with this regimen.
5. Determine the pharmacology and pharmacokinetics of this drug in these patients.
6. Determine whether this regimen facilitates adaptive or innate immunity in vivo or serum antibody responses to tumor-associated antigens in these patients.
7. 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.

Entry Criteria

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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Zubrod 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute granulocyte count greater than 1,500/mm³
• Platelet count at least 100,000/mm³
• Lymphocyte count greater than 600/mm³

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Renato Lenzi, MD, Protocol chair		Ph: 713-792-2828; 800-392-1611

Registry Information
Official Title		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
Trial Start Date		2001-07-16
Registered in ClinicalTrials.gov		NCT00016289
Date Submitted to PDQ		2001-03-21
Information Last Verified		2006-01-17
NCI Grant/Contract Number		CA16672

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