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Home > "I" Clinical Trials Conditions > Interleukin-12 in Treating Patients With Cancer in the Abdomen  Interleukin-12 in Treating Patients With Cancer in the Abdomen
Interleukin-12 in Treating Patients With Cancer in the Abdomen
For Condition: Gastric Cancer,Colorectal Cancer,Colon Cancer,Rectal Cancer,Pancreatic Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , M.D. Anderson Cancer Center
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry 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)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RenatoLenzi, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000065681; MDA-ID-97027,NCI-T97-0034
Study Start Date: August 1997
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003046
Other Colon Cancer Studies:
1. Aminocamptothecin in Treating Patients With Advanced Cancer of the Peritoneal Cavity
2. Intraperitoneal and Intravenous Gemcitabine, Radiotherapy and Surgery for Advanced Cancer of the Pancreas
3. Vaccine Therapy with Tumor Specific Mutated P53 or Ras Peptides Alone or in Combination with Cellular Immunotherapy with Peptide Activated Lymphocytes (PAL Cells) Along with Subcutaneous IL-2
4. Study of Combined RHUMAB VEGF and Capecitabine-based Chemoradiation for Patients with Locally Advanced Pancreatic Cancer
5. Interleukin-12 in Treating Patients With Cancer in the Abdomen
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Interleukin-12 in Treating Patients With Cancer in the Abdomen
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