Clinical Trial: Interleukin-12 in Treating Patients With Advanced or Recurrent Cancer of the Cervix

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cervical cancer cells. PURPOSE: Phase II trial to study the effectiveness of interleukin-12 in treating patients with advanced or recurrent cancer of the cervix.

Condition Treatment or Intervention Phase
recurrent cervical cancer
cervical squamous cell carcinoma
cervical adenocarcinoma
stage IV cervical cancer
cervical adenosquamous cell carcinoma
 Drug: interleukin-12
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Cervical Cancer;   Soft Tissue Sarcoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Interleukin-12 (IL-12) in Patients With Advanced, Recurrent, or Inoperable Carcinoma of the Cervix

Further Study Details: 

Study start: July 1997

OBJECTIVES: I. Determine the response rates, duration of response, and survival in women with advanced, recurrent, or inoperable cervical cancer treated with interleukin-12. II. Determine the toxic effects of systemic interleukin-12 in these patients. III. Correlate response to therapy and survival with the presence or absence of human papilloma virus (HPV), and the specific subtype of HPV, in these patients.

PROTOCOL OUTLINE: Patients are stratified according to prior chemotherapy (yes vs no). Patients receive induction interleukin-12 IV over 5-20 seconds on day -13 and then daily on days 1-5. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 78 patients (39 per stratum) will be accrued for this study within 26 months.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

  • Biologic therapy: 1 prior biologic therapy allowed; At least 4 weeks since prior biologic therapy
  • Chemotherapy: 1 prior adjuvant chemotherapy regimen allowed 1 prior chemotherapy regimen for advanced disease allowed; At least 4 weeks since prior chemotherapy; No concurrent chemotherapy
  • Endocrine therapy: No concurrent steroid therapy; No concurrent megestrol acetate
  • Radiotherapy: See Disease Characteristics; No concurrent radiotherapy
  • Surgery: See Disease Characteristics; At least 2 weeks since prior surgery

--Patient Characteristics--

  • Age: 18 and over
  • Performance status: ECOG 0-1
  • Life expectancy: Not specified
  • Hematopoietic: WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3
  • Hepatic: Bilirubin no greater than 1.5 times the upper limit of normal (ULN); AST and ALT no greater than 2 times ULN
  • Renal: Creatinine no greater than 2.0 mg/dL; Creatinine clearance at least 60 mL/min
  • Cardiovascular: No New York Heart Association class III/IV heart disease; No uncontrolled congestive heart failure or angina
  • Pulmonary: No chronic obstructive pulmonary disease
  • Gastrointestinal: No evidence of active gastrointestinal bleeding; No active peptic ulcer disease; No inflammatory bowel disease
  • Other: Normal diet required; No known active infections; HIV negative; AIDS-related complex (ARC) negative; No substance abuse or psychiatric problems; No evidence of autoimmune disease; No other prior invasive malignancy except resected basal cell or squamous cell skin cancer; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception

Location Information


Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States

New Jersey
      CCOP - Northern New Jersey, Hackensack,  New Jersey,  07601,  United States

      Hunterdon Regional Cancer Center, Flemington,  New Jersey,  08822,  United States

New York
      Albert Einstein Comprehensive Cancer Center, Bronx,  New York,  10461,  United States

      NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York,  New York,  10016,  United States

      University of Rochester Cancer Center, Rochester,  New York,  14642,  United States

Pennsylvania
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States

      University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15213,  United States

Tennessee
      Vanderbilt Cancer Center, Nashville,  Tennessee,  37232-6838,  United States

Study chairs or principal investigators

Scott Wadler,  Study Chair,  Eastern Cooperative Oncology Group   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000065597; E-1E96
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003017
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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