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| ID | Type | Description | Link |
|---|---|---|---|
| PCI-98-031 | |||
| PCI-MWH-97-039 | |||
| NCI-T97-0031 | |||
| CDR0000066467 | Registry Identifier | PDQ (Physician Data Query) |
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Phase I trial to study the effectiveness of interleukin-12 in treating patients with refractory ovarian or abdominal cancers. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a persons's white blood cells to kill cancer cells.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant interleukin-12 | Biological |
|
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Robert P. Edwards, MD | University of Pittsburgh | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D003110 | Colonic Neoplasms |
| D013274 | Stomach Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D012004 | Rectal Neoplasms |
| D001005 | Anus Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| D006528 | Carcinoma, Hepatocellular |
| D016889 | Endometrial Neoplasms |
| D005706 | Gallbladder Neoplasms |
| D001650 | Bile Duct Neoplasms |
| D011471 | Prostatic Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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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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| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D012002 | Rectal Diseases |
| D001004 | Anus Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010051 | Ovarian Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D000230 | Adenocarcinoma |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D001661 | Biliary Tract Neoplasms |
| D001660 | Biliary Tract Diseases |
| D005705 | Gallbladder Diseases |
| D001649 | Bile Duct Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D005184 | Fallopian Tube Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |