RATIONALE: Interleukin-12 may kill tumor cells by stimulating a person's white blood cells to kill cancer cells. PURPOSE: Phase I trial to study the effectiveness of interleukin-12 in treating patients with cancer in the abdomen.

Condition	Treatment or Intervention	Phase
Pancreatic Cancer Gastric Cancer Colorectal Cancer Colon Cancer Rectal Cancer	Drug: interleukin-12	Phase I

Further Study Details: 

OBJECTIVES: I. Determine the maximum tolerated dose of intraperitoneal interleukin-12 in patients with Mullerian carcinoma (closed to accrual as of 8/23/01), gastrointestinal carcinoma, or peritoneal mesothelioma (closed to accrual as of 8/23/01). II. Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.

PROTOCOL OUTLINE: This is a dose-escalation, multicenter study. Patients receive intraperitoneal interleukin-12 over 30 minutes once weekly for 4 weeks. Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients with stable or responsive disease may receive an additional 6 courses. Patients receive escalating doses of intraperitoneal interleukin-12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is established, additional patients are accrued to receive interleukin-12 at the recommended dose.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study within 2 years.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically confirmed; Mullerian carcinoma (ovarian epithelial or peritoneal carcinoma) (closed to accrual as of 8/23/01) OR Gastrointestinal cancer with abdominal carcinomatosis OR Peritoneal mesothelioma (closed to accrual as of 8/23/01)
• Must have received an adequate course of any platinum-based chemotherapy regimen for ovarian cancer with evidence of intraabdominal disease
• Must have received an adequate course of fluorouracil-based treatment for metastatic colon cancer
• Intact primary gastrointestinal tumor allowed if not at risk of obstruction and/or bleeding
• Abdominal lesions must be less than 10 cm
• Extraperitoneal lesions must be less than 2 cm
• No hepatic disease
• No clinically significant pleural effusion (controlled by pleurodesis allowed)
• No brain metastases
• No significant adhesions or symptoms of obstruction

--Prior/Concurrent Therapy--

• Biologic therapy: No other concurrent immunotherapy
• Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered; No concurrent chemotherapy
• Endocrine therapy: No chronic steroid therapy
• Radiotherapy: At least 3 months since prior localized radiotherapy (e.g., pelvic or small field) and recovered; No radiotherapy to whole abdomen; No concurrent radiotherapy
• Surgery: Recovered from prior surgery; At least 3 weeks since prior major abdominal surgery; At least 2 weeks since prior laparoscopy

--Patient Characteristics--

• Age: 18 and over
• Performance status: Zubrod 0-2
• Life expectancy: Not specified
• Hematopoietic: Absolute granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL (transfusion allowed); Lymphocyte count at least 800/mm3
• Hepatic: See Disease Characteristics; Bilirubin no greater than 1.5 mg/dL; SGOT or SGPT less than 2.5 times upper limit of normal; Albumin at least 3.5 g/dL; Hepatitis B and C negative
• Renal: Creatinine no greater than 1.5 mg/dL
• Cardiovascular: No significant heart disease
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; Loss of no more than 10% of body weight over a 4 month period; No overt autoimmune disease; No active ulcer disease; No prior inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)

Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Study chairs or principal investigators

Renato Lenzi,  Study Chair,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000065681; MDA-ID-97027; NCI-T97-0034
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003046
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08