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A Phase I Dose-Escalating Study of Recombinant Human Interleukin-12 (NSC # 672423) Administered by Intraperitoneal Infusion in Refractory Advanced Stage Ovarian Cancer and Other Abdominal Carcinomatosis


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

A Phase I Dose-Escalating Study of Recombinant Human Interleukin-12 (NSC # 672423) Administered by Intraperitoneal Infusion in Refractory Advanced Stage Ovarian Cancer and Other Abdominal Carcinomatosis


OBJECTIVES:

I. Assess the safety and maximum tolerated dose of recombinant human interleukin-12
(rhIL-12) administered by intraperitoneal infusion in patients with chemotherapy refractory
advanced ovarian cancer and other diffuse abdominal carcinomatosis.

II. Determine the immunopharmacologic profile of rhIL-12 in this patient population.

III. Evaluate the biologic response in selected patients to rhIL-12 administered through
intraperitoneal infusions.

OUTLINE: This is a dose escalation, multicenter study.

Cohorts of 3-6 patients each receive escalating doses of intraperitoneal recombinant human
interleukin-12 (rhIL-12) administered weekly for 9 weeks. If a patient tolerates rhIL-12 and
shows evidence of objective response or stable disease, patient may receive up to 9
additional weeks of treatment. Treatment continues in the absence of unacceptable toxicity
or disease progression. Dose escalation continues until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding that at which no more than 1 of 6
patients experiences dose limiting toxicity.

All patients are followed for survival.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed intraabdominal cancer

- Diffuse abdominal carcinomatosis Chemotherapy refractory advanced stage ovarian
cancer

- Measurable disease

- Residual, recurrent, or metastatic disease beyond the scope of standard curative
therapy

- Extension of disease to sites distant to the peritoneal cavity allowed
Retroperitoneal lymphadenopathy allowed as long as there is evaluable intraabdominal
disease

- No history of progressive brain metastases

PATIENT CHARACTERISTICS:

- Age: 18 and over

- Performance status: Karnofsky 70-100%

- Hemoglobin greater than 9 g/dL

- WBC greater than 3,000/mm3

- Platelet count greater than 100,000/mm3

- Bilirubin less than 2.0 mg/dL

- ALT less than 100 U/L

- Creatinine clearance greater than 60 mL/min

- Normal electrocardiogram

- No recent history of cardiac ischemia

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Hepatitis B negative

- No evidence of clinical immunodeficiency syndromes or immunodeficiency associated
diseases

- No history of autoimmune disease

- No concurrent major illness

- No serious infection requiring intravenous antibiotics

- No active peptic ulcer disease

- Must have free flow of fluid into the peritoneal space

- No leakage from the catheter exit site

PRIOR CONCURRENT THERAPY:

- At least 3 weeks since prior biologic therapy (6 weeks for interleukin-2)

- No prior recombinant human interleukin-12

- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)

- No concurrent systemic chemotherapy

- No concurrent systemic corticosteroids

- No prior radiation therapy to the whole abdomen

- No concurrent radiotherapy

- At least 3 weeks since prior exposure to any investigational drug

- No concurrent investigational drug

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Robert P. Edwards, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02272

NCT ID:

NCT00003439

Start Date:

August 1998

Completion Date:

Related Keywords:

  • 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
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • metastatic gastrointestinal carcinoid tumor
  • recurrent gastrointestinal carcinoid tumor
  • advanced adult primary liver cancer
  • recurrent adult primary liver cancer
  • stage IV endometrial carcinoma
  • recurrent endometrial carcinoma
  • 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 prostate cancer
  • recurrent prostate cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • stage IV pancreatic cancer
  • Ovarian Neoplasms

Name

Location

University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213