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


Phase 1
18 Years
N/A
Not Enrolling
Both
Anal Cancer, Colorectal Cancer, Gallbladder Cancer, Gastric Cancer, Pancreatic Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) of Intraperitoneal Interleukin-12

Outcome Description:

MTD found in absence of unacceptable toxicity or disease progression with each 4 week treatment cycle.

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Principal Investigator

Renato Lenzi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

ID97-027

NCT ID:

NCT00003046

Start Date:

August 1997

Completion Date:

October 2001

Related Keywords:

  • Anal Cancer
  • Colorectal Cancer
  • Gallbladder Cancer
  • Gastric Cancer
  • Pancreatic Cancer
  • 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
  • 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
  • advanced malignant mesothelioma
  • recurrent malignant mesothelioma
  • small intestine adenocarcinoma
  • unresectable gallbladder cancer
  • recurrent gallbladder cancer
  • unresectable extrahepatic bile duct cancer
  • recurrent extrahepatic bile duct cancer
  • recurrent small intestine cancer
  • stage IV pancreatic cancer
  • Anus Neoplasms
  • Colorectal Neoplasms
  • Stomach Neoplasms
  • Pancreatic Neoplasms
  • Gallbladder Neoplasms

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009