Interleukin-12 in Treating Patients With Refractory Advanced-Stage Ovarian Cancer or Abdominal Ca… (NCT00003439) | Clinical Trial Compass
CompletedPhase 1
Interleukin-12 in Treating Patients With Refractory Advanced-Stage Ovarian Cancer or Abdominal Cancer
United States36 participantsStarted 1998-08
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 wee…