Mesothelioma Related Clinical Trials:
Phase I Study of Intraperitoneal Recombinant Human Interleukin-12 (rhIL-12) in Patients With Peritoneal Carcinomatosis, Associated With Mullerian and Gastrointestinal Carcinomas

   

Status: Active
Sponsors and Collaborators: M.D. Anderson Cancer Center; National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
Government Identifier: NCT00003046

Condition: Anal Cancer; Carcinoma of the Appendix; Colorectal Cancer; Extrahepatic Bile Duct Cancer; Gallbladder Cancer; Gastric Cancer; Gastrointestinal Carcinoid Tumor; Malignant Mesothelioma; Pancreatic Cancer; Small Intestine Cancer
Intervention: Drug: recombinant interleukin-12; Procedure: interleukin therapy; Procedure: intraperitoneal chemotherapy


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Purpose:


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.

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase I Study of Intraperitoneal Recombinant Human Interleukin-12 (rhIL-12) in Patients With Peritoneal Carcinomatosis, Associated With Mullerian and Gastrointestinal Carcinomas


Estimated Enrollment:   40
Study Start Date:   August 1997

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.

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.


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Eligibility:

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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)

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


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Contacts and Locations:

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003046
Locations
United States, Texas
University of Texas - MD Anderson Cancer Center    
      Houston, Texas, United States, 77030-4009

Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Renato Lenzi, MD     M.D. Anderson Cancer Center    

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Additional Information:

Publications of Results:
Lenzi R, Kudelka AP, Veschraegen C, et al.: Intraperitoneal (IP) bioimmunologic responses in patients with ovarian and gastrointestinal cancers at a low toxicity dosing schedule of IP recombinant interleukin-12 (rhIL-12). [Abstract] Proc Am Assoc Cancer Res 40: A3778, 573, 1999.

Study ID Numbers:   CDR0000065681, MDA-ID-97027, NCI-T97-0034
First Received:   November 1, 1999
Last Updated:   October 25, 2007
ClinicalTrials.gov Identifier:   NCT00003046
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
advanced malignant mesothelioma  
recurrent malignant mesothelioma  
stage IV colon cancer  
stage IV gastric cancer  
recurrent gastric cancer  
recurrent pancreatic cancer  
stage IV rectal cancer  
recurrent colon cancer  
recurrent rectal cancer  
stage IV anal cancer  
recurrent anal cancer
metastatic gastrointestinal carcinoid tumor
recurrent gastrointestinal carcinoid tumor
small intestine adenocarcinoma
unresectable gallbladder cancer
recurrent gallbladder cancer
unresectable extrahepatic bile duct cancer
recurrent extrahepatic bile duct cancer
recurrent small intestine cancer
carcinoma of the appendix

Study placed in the following topic categories:
Gallbladder Diseases
Interleukin-12
Rectal Neoplasms
Gastrointestinal Diseases
Pancreatic Neoplasms
Colonic Diseases
Rectal Diseases
Duodenal Neoplasms
Stomach Diseases
Ileal Neoplasms
Biliary Tract Diseases
Stomach Neoplasms
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Rectal cancer
Duodenal Diseases
Endocrine Gland Neoplasms
Bile duct cancer, extrahepatic
Jejunal Neoplasms
Biliary Tract Neoplasms

Additional relevant MeSH terms:
Mesothelioma
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Neoplasms, Mesothelial
Growth Substances
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Adjuvants, Immunologic
Endocrine System Diseases
Angiogenesis Inhibitors
Ileal Diseases
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Jejunal Diseases
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

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