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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA016672 | U.S. NIH Grant/Contract | View source | |
| MDA-ID-97027 | Other Identifier | UT MD Anderson Cancer Center | |
| NCI-T97-0034 | |||
| CDR0000065681 | Registry Identifier | NCI PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interleukin-12 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Interleukin-12 | Biological | Intraperitoneal over 30 minutes once weekly for 4 weeks, repeats every 4 weeks for up to 6 courses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Intraperitoneal Interleukin-12 | MTD found in absence of unacceptable toxicity or disease progression with each 4 week treatment cycle. | 4 weeks |
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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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| Name | Affiliation | Role |
|---|---|---|
| Renato Lenzi, MD | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. |
| Label | URL |
|---|---|
| UT MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| D015179 | Colorectal Neoplasms |
| D005706 | Gallbladder Neoplasms |
| D013274 | Stomach Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D001063 | Appendiceal Neoplasms |
| D001650 | Bile Duct Neoplasms |
| D000086002 | Mesothelioma, Malignant |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D053765 | Interleukin-12 Subunit p35 |
| ID | Term |
|---|---|
| D018664 | Interleukin-12 |
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D003108 | Colonic Diseases |
| D001661 | Biliary Tract Neoplasms |
| D001660 | Biliary Tract Diseases |
| D005705 | Gallbladder Diseases |
| D013272 | Stomach Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D002430 | Cecal Neoplasms |
| D002429 | Cecal Diseases |
| D001649 | Bile Duct Diseases |
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |