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Interleukin-12 in Treating Patients With Previously Treated Non-Hodgkin's Lymphoma or Hodgkin's Disease



Interleukin-12 in Treating Patients With Previously Treated Non-Hodgkin's Lymphoma or Hodgkin's Disease

For Condition: Lymphocytic Lymphoma,Myeloid Leukemia,Hodgkin's Disease,Skin Cancer,Plasma Cell Tumor
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , M.D. Anderson Cancer 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 lymphoma cells. PURPOSE: Phase II trial to study the effectiveness of interleukin-12 in treating patients with previously treated non-Hodgkin's lymphoma or Hodgkin's disease.
Details: OBJECTIVES: I. Determine the response rate of interleukin-12 in previously treated patients with non-Hodgkin's lymphoma or Hodgkin's disease. PROTOCOL OUTLINE: Patients are stratified according to disease characteristics: low grade non-Hodgkin's lymphoma (follicular small cleaved, follicular mixed, small lymphocytic, and variants) versus intermediate grade non-Hodgkin's lymphoma (follicular large, diffuse large, diffuse mixed, immunoblastic, peripheral T-cell, and mantle cell) versus Hodgkin's disease. Patients receive interleukin-12 subcutaneously twice a week. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 36-105 patients will be accrued for this study.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Previously treated non-Hodgkin's lymphoma (all histologies except lymphoblastic and Burkitt's lymphoma) or Hodgkin's disease - Maximum of 4 previous treatment regimens - Measurable disease - No CNS involvement A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. --Prior/Concurrent Therapy-- Biologic therapy: - No prior allogeneic bone marrow or stem cell transplant - At least 3 weeks since prior biologic therapy for lymphoma Chemotherapy: At least 3 weeks since prior chemotherapy for lymphoma Endocrine therapy: - No concurrent steroid therapy - At least 3 weeks since prior endocrine therapy for lymphoma Radiotherapy: At least 3 weeks since prior radiotherapy for lymphoma Surgery: At least 2 weeks since prior surgery --Patient Characteristics-- Age: 16 and over Performance status: - Zubrod 0-1 - Karnofsky 80-100% Life expectancy: At least 12 weeks Hematopoietic: - Platelet count at least 75,000/mm3 - Absolute neutrophil count greater than 1500/mm3 - Lymphocyte count greater than 500/mm3 - Hemoglobin at least 8.0 g/dL Hepatic: - Bilirubin less than 1.5 mg/dL - SGOT/SGPT less than 2 times normal Renal: - Creatinine no greater than 1.6 mg/dL - Creatinine clearance at least 60 mL/min Cardiovascular: No severe cardiovascular disease including active ischemic heart disease, congestive heart failure, or major arrhythmias Pulmonary: No severe pulmonary disease including dyspnea with moderate to severe exertion Other: - HIV negative - No active infection - Not pregnant or nursing - Fertile patients must use adequate contraception - No clinically significant autoimmune disease (e.g. rheumatoid arthritis) - No clinically significant gastrointestinal bleeding or uncontrolled peptic ulcer
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
AnasYounes,  Study Chair,  M.D. Anderson Cancer Center

University of Texas - MD Anderson Cancer Center
Houston,  Texas,  77030-4009
United States
 


Additional Information:
Study ID Numbers:
  CDR0000066067;  MDA-DM-97073,NCI-T97-0050
Study Start Date: February 1998
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003210

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2. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia or Myelodysplastic Syndrome

3. Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia

4. Irinotecan and Cytarabine in Treating Patients With Refractory or Recurrent Acute Myeloid Leukemia or Chronic Myelogenous Leukemia

5. Interleukin-12 in Treating Patients With Previously Treated Non-Hodgkin's Lymphoma or Hodgkin's Disease

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