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

NCT00003017 | Completed Phase 2

• 2 other identifiers: CDR0000065597ECOG-E1E96
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 9

Brief Summary

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 cancer cells in the cervix. PURPOSE: Phase II trial to study the effectiveness of interleukin-12 in treating patients who have advanced or recurrent cancer of the cervix.

Conditions

Cervical Cancer

Keywords

stage IV cervical cancer; recurrent cervical cancer; cervical squamous cell carcinoma; cervical adenocarcinoma; cervical adenosquamous cell carcinoma

Interventions

recombinant interleukin-12 BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically proven stage IV or recurrent squamous cell, adenosquamous, or adenocarcinoma of the uterine cervix including: Lung, liver, lymph node, or skin metastases OR Retroperitoneal disease OR Other advanced measurable disease OR Positive paraaortic lymph nodes Measurable disease that is beyond the scope of conventional radiation therapy or surgery, or recurrent after radiation therapy or surgery Measurable, recurrent disease within a previously irradiated field must have increased in size by 100% on at least 2 successive scans, MRI, or physical examinations 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 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (9)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Hunterdon Regional Cancer Center

Flemington, New Jersey, 08822, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Related Publications (1)

• Wadler S, Levy D, Frederickson HL, Falkson CI, Wang Y, Weller E, Burk R, Ho G, Kadish AS; Eastern Cooperative Oncology Group. A phase II trial of interleukin-12 in patients with advanced cervical cancer: clinical and immunologic correlates. Eastern Cooperative Oncology Group study E1E96. Gynecol Oncol. 2004 Mar;92(3):957-64. doi: 10.1016/j.ygyno.2003.12.022.

  PMID: 14984966 RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Interleukin-12 Subunit p35

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Interleukin-12; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Scott Wadler, MD

  Albert Einstein College of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: April 22, 2004
• Study Start: July 1, 1997
• Study Completion: August 1, 2005
• Last Updated: June 21, 2013

Record last verified: 2004-07

Locations

US (9)