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Interleukin-12 Plus Interleukin-2 in Treating Patients With Advanced Solid Tumors



Interleukin-12 Plus Interleukin-2 in Treating Patients With Advanced Solid Tumors

For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Beth Israel Deaconess Medical Center
Synopsis: 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. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining the two drugs may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of interleukin-12 plus interleukin-2 in treating patients who have advanced solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of low-dose interleukin-2 administered with interleukin-12 in patients with advanced solid malignancies. II. Determine the toxicity of this regimen in these patients. III. Determine the anti-tumor effects of this regimen in these patients. IV. Determine the impact of interleukin-2 on the magnitude and duration of in vivo immune activation induced by interleukin-12 in these patients. PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive interleukin-12 (IL-12) IV on days 1 and 4 for 6 weeks. Beginning on day 4 of the third week, patients receive interleukin-2 (IL-2) subcutaneously 1 hour before and 20 hours after each dose of IL-12. On subsequent courses, IL-2 and IL-12 are administered on days 1 and 4 of each week. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease response may continue treatment until complete response or disease progression. Cohorts of 3-6 patients receive escalating doses of IL-12 and IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 3 weeks. PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study within 2 years.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed metastatic or unresectable solid tumor that is unlikely to respond to existing therapy or for which no curative therapy exists Measurable or evaluable disease which is clearly progressive No hematologic malignancies No brain metastases --Prior/Concurrent Therapy-- Biologic therapy: - At least 4 weeks since prior immunotherapy and recovered - At least 6 months since prior interleukin-2 - At least 12 months since prior interleukin-12 - No more than 2 prior biological response modifier treatment regimens Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for prior nitrosoureas or mitomycin) and recovered - No more than 2 prior chemotherapy regimens - No concurrent chemotherapy Endocrine therapy: - At least 4 weeks since prior hormonal therapy and recovered - No concurrent hormonal therapy (including steroids and hormone replacement therapy) Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered - No concurrent radiotherapy Surgery: No prior organ allografts Other: - At least 2 weeks since prior IV antibiotics - No other concurrent investigational agents --Patient Characteristics-- Age: 18 and over Performance status: - ECOG 0-1 - Karnofsky 80-100% Life expectancy: At least 3 months Hematopoietic: - WBC greater than 4,000/mm3 - Absolute neutrophil count greater than 1,500/mm3 - Platelet count greater than 100,000/mm3 Hepatic: - Bilirubin less than 1.5 mg/dL - SGOT and SGPT less than 2 times normal - No active (clinical or subclinical) hepatitis B or C infection Renal: - Creatinine less than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No congestive heart failure - No symptoms of coronary artery disease - No serious cardiac arrhythmias - No evidence of prior myocardial infarction Other: - No active infection requiring antibiotic therapy - No medical condition requiring the use of corticosteroids during study - No autoimmune or rheumatologic disease - No seizure disorders - No significant medical disease that would preclude study - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JaredGollob,  Study Chair,  Beth Israel Deaconess Medical Center

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


Additional Information:
Study ID Numbers:  CDR0000067723;  NCI-65,BIH-99-1332
Study Start Date: June 2000
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005604

Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
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2. Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors

3. LY317615 Plus Capecitabine in Treating Patients With Advanced Solid Tumors

4. Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer

5. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

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