NCT00003017CompletedPhase 2
Phase II Clinical Trial of Interleukin-12 in Patients With Advanced, Recurrent or Inoperable Carcinoma of the Cervix
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Locations
- 9
Study Overview
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.
Detailed Description
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.
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- Not provided
Investigators
Study Sites (9)
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Interleukin-12 and Trastuzumab in Treating Patients With Cancer That Has High Levels of HER2/NeuMetastatic Transitional Cell Cancer of the Renal Pelvis and UreterGastrinomaLiver MetastasesLocalized Unresectable Adult Primary Liver CancerLung MetastasesMalignant Pericardial EffusionMetastatic Gastrointestinal Carcinoid TumorMetastatic Parathyroid CancerRecurrent Breast CancerRecurrent Carcinoma of Unknown PrimaryRecurrent Cervical CancerRecurrent Colon CancerRecurrent Endometrial CarcinomaRecurrent Esophageal CancerRecurrent Extrahepatic Bile Duct CancerRecurrent Gallbladder CancerRecurrent Gastric CancerRecurrent Gastrointestinal Carcinoid TumorRecurrent Islet Cell CarcinomaRecurrent Malignant Testicular Germ Cell TumorRecurrent Squamous Cell Carcinoma of the NasopharynxStage IV Adenoid Cystic Carcinoma of the Oral CavityGlucagonomaAdvanced Adult Primary Liver CancerAnaplastic Thyroid CancerBone MetastasesCarcinoma of the AppendixDistal Urethral CancerFallopian Tube CancerNewly Diagnosed Carcinoma of Unknown PrimaryOccult Non-small Cell Lung CancerPrimary Peritoneal Cavity CancerProximal Urethral CancerPulmonary Carcinoid TumorMale Breast CancerMalignant Pleural EffusionPancreatic Polypeptide TumorInsulinomaInflammatory Breast CancerRecurrent Adenoid Cystic Carcinoma of the Oral CavityRecurrent Adrenocortical CarcinomaRecurrent Adult Primary Liver CancerRecurrent Anal CancerRecurrent Bladder CancerRecurrent Mucoepidermoid Carcinoma of the Oral CavityRecurrent Non-small Cell Lung CancerRecurrent Ovarian Epithelial CancerRecurrent Pancreatic CancerRecurrent Parathyroid CancerRecurrent Prostate CancerRecurrent Rectal CancerRecurrent Renal Cell CancerRecurrent Salivary Gland CancerRecurrent Small Intestine CancerRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Thyroid CancerRecurrent Transitional Cell Cancer of the Renal Pelvis and UreterRecurrent Urethral CancerRecurrent Vaginal CancerRecurrent Vulvar CancerSkin MetastasesSmall Intestine AdenocarcinomaSomatostatinomaStage III Adenoid Cystic Carcinoma of the Oral CavityStage III Adrenocortical CarcinomaStage III Bladder CancerStage III Cervical CancerStage III Colon CancerStage III Endometrial CarcinomaStage III Esophageal CancerStage III Follicular Thyroid CancerStage III Gastric CancerStage III Malignant Testicular Germ Cell TumorStage III Mucoepidermoid Carcinoma of the Oral CavityStage III Ovarian Epithelial CancerStage III Pancreatic CancerStage III Papillary Thyroid CancerStage III Prostate CancerStage III Rectal CancerStage III Renal Cell CancerStage III Salivary Gland CancerStage III Squamous Cell Carcinoma of the LarynxStage III Squamous Cell Carcinoma of the Lip and Oral CavityStage III Squamous Cell Carcinoma of the NasopharynxStage III Squamous Cell Carcinoma of the OropharynxStage III Vaginal CancerStage III Vulvar CancerStage IIIA Anal CancerStage IIIA Breast CancerStage IIIA Non-small Cell Lung CancerStage IIIB Anal CancerStage IIIB Breast CancerStage IIIB Non-small Cell Lung CancerStage IV Adrenocortical CarcinomaStage IV Anal CancerStage IV Bladder CancerStage IV Breast CancerStage IV Colon CancerStage IV Endometrial CarcinomaStage IV Esophageal CancerStage IV Follicular Thyroid CancerStage IV Gastric CancerStage IV Mucoepidermoid Carcinoma of the Oral CavityStage IV Papillary Thyroid CancerStage IV Prostate CancerStage IV Non-small Cell Lung CancerStage IV Rectal CancerStage IV Ovarian Epithelial CancerStage IV Pancreatic CancerStage IV Renal Cell CancerStage IV Salivary Gland CancerStage IV Squamous Cell Carcinoma of the LarynxStage IV Squamous Cell Carcinoma of the Lip and Oral CavityStage IVA Cervical CancerStage IVA Vaginal CancerStage IVB Cervical CancerStage IVB Vaginal CancerStage IVB Vulvar CancerStage IV Squamous Cell Carcinoma of the NasopharynxStage IV Squamous Cell Carcinoma of the OropharynxThyroid Gland Medullary CarcinomaUnresectable Extrahepatic Bile Duct CancerUnresectable Gallbladder CancerUrethral Cancer Associated With Invasive Bladder CancerWDHA SyndromeNCT00004074National Cancer Institute (NCI)15
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