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Interleukin-2 Immunotoxin Therapy in Treating Patients With Indolent Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Interleukin-2 Immunotoxin Therapy in Treating Patients With Indolent Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Interleukin-2 Immunotoxin Therapy in Treating Patients With Indolent Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma Clinical research trials and Interleukin-2 Immunotoxin Therapy in Treating Patients With Indolent Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Interleukin-2 Immunotoxin Therapy in Treating Patients With Indolent Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma. Interleukin-2 Immunotoxin Therapy in Treating Patients With Indolent Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Interleukin-2 Immunotoxin Therapy in Treating Patients With Indolent Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma clinical trial. Subjects frequently obtain the most expert healthcare possible for their Interleukin-2 Immunotoxin Therapy in Treating Patients With Indolent Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Interleukin-2 Immunotoxin Therapy in Treating Patients With Indolent Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma  Interleukin-2 Immunotoxin Therapy in Treating Patients With Indolent Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
Interleukin-2 Immunotoxin Therapy in Treating Patients With Indolent Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
For Condition: Lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group
Synopsis: RATIONALE: Immunotoxins can locate cancer cells and kill them without harming normal cells. This may be an effective treatment for non-Hodgkin's lymphoma. PURPOSE: Phase II trial to study the effectiveness of interleukin-2 immunotoxin therapy in treating patients who have indolent stage II, stage III, or stage IV non-Hodgkin's lymphoma that has not responded to previous treatment.
Details: OBJECTIVES: I. Determine the response rate to DAB389 interleukin-2 immunotoxin therapy in patients with previously treated stage I, II, III, or IV indolent non-Hodgkin's lymphoma. II. Determine the time to progression, duration of remission, and time to treatment failure of these patients after this therapy. III. Determine the toxicity of this regimen in these patients. IV. Correlate the results of the IL-2 receptor assay with treatment outcomes. PROTOCOL OUTLINE: Patients are stratified according to IL-2 receptor classification (positive vs negative). Patients receive DAB389 interleukin-2 immunotoxin therapy IV over 15-60 minutes on days 1-5 every 21 days. Patients receive 2-6 courses of therapy. Patients are followed every 3 months for the first 2 years, every 6 months for the next 3 years, then annually thereafter. PROJECTED ACCRUAL: Patients will be accrued separately for the two strata. A total of 33 patients will be accrued for the IL-2 receptor positive stratum. A total of 10-44 patients will be accrued for the IL-2 receptor negative stratum.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven indolent stage I, II, III, or IV non-Hodgkin's lymphoma; Small lymphocytic lymphoma; Follicular small cleaved cell lymphoma; Follicular mixed cell lymphoma; Follicular large cell lymphoma - At least one bidimensionally measurable site; At least 1.5 cm in its greatest dimension; Not in field of prior radiotherapy - Progressive disease after at least one prior treatment regimen for lymphoma --Prior/Concurrent Therapy-- - Biologic therapy: Prior stem cell transplant allowed; At least 4 weeks since prior biologic therapy; No other concurrent immunotherapy - Chemotherapy: At least 4 weeks since prior chemotherapy; No concurrent chemotherapy - Endocrine therapy: At least 4 weeks since prior endocrine therapy; No concurrent hormone therapy (except contraceptives and replacement steroids); No concurrent corticosteroids - Radiotherapy: See Disease Characteristics; At least 4 weeks since prior radiotherapy - Surgery: Not specified - Other: No other experimental medications (including approved drugs tested in an investigational setting) --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1000/mm3; Platelet count at least 50,000/mm3; Hemoglobin at least 8 g/dL - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); ALT or AST no greater than 2.0 times ULN; No hepatitis B or C infection; Albumin greater than 3.0 g/dL - Renal: Creatinine no greater than ULN - Other: Not pregnant or nursing; Fertile patients must use effective contraception; HIV negative; No active infection requiring anti-infective therapy; No other prior invasive malignancy within past 5 years, except: Curatively treated basal or squamous cell carcinoma of the skin; Carcinoma in situ of the cervix
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TimothyKuzel, Study Chair, Eastern Cooperative Oncology Group
Morristown Memorial Hospital
Morristown, New Jersey, 07962-1956
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
Hunterdon Regional Cancer Center
Flemington, New Jersey, 08822
United States
Riverview Medical Center - Booker Cancer Center
Red Bank, New Jersey, 07701
United States
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, 07201
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Overlook Hospital
Summit, New Jersey, 07902-0220
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Additional Information:
Study ID Numbers: CDR0000066692; E-1497
Study Start Date: March 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003615
Other Lymphoma Studies:
1. BMS-247550 in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction
2. Clinical, Laboratory and Epidemiologic Pilot Studies of Individuals at High Risk for Viral-Associated Cancers
3. Ganciclovir Plus Arginine Butyrate in Treating Patients With Cancer or Lymphoproliferative Disorders Associated with the Epstein Barr Virus
4. Monoclonal Antibody Therapy in Treating Patients With Refractory Advanced Solid Tumors or Lymphoma
5. Combination Chemotherapy in Treating Patients With Advanced Cancer
Related Studies:
Other Lymphoma Clinical Trials
Other New Jersey Clinical Trials
Other Morristown Clinical Trials
Interleukin-2 Immunotoxin Therapy in Treating Patients With Indolent Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
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