|
Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma Clinical research trials and Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma. Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma clinical trial. Human subjects often get the best healthcare available for their Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma  Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma
Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma
For Condition: anaplastic large cell lymphoma,recurrent adult Hodgkin's lymphoma
Status: Recruiting
Sponsor(s): Beth Israel Deaconess Medical Center ,
Synopsis: RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients with refractoryanaplastic large cell lymphoma or Hodgkin's lymphoma.
Details: OBJECTIVES: - Determine the safety and tolerability of multiple doses of monoclonal antibody HeFi-1 in patients with CD30+ anaplastic large cell lymphoma or Hodgkin's lymphoma. - Determine the pharmacokinetics of this drug in this patient population. - Evaluate the efficacy, in terms of correlating immunologic parameters and immunogenicity, of this drug in these patients. OUTLINE: This is an open-label, dose-escalation study. Patients receive monoclonal antibody HeFi-1 IV over 30 minutes 3 times a week for 2 weeks. Treatment may continue for 2 additional weeks in the absence of anti-HeFi-1 response. Responding patients may continue treatment at monthly intervals for one year. Cohorts of 3-4 patients receive escalating doses of monoclonal antibody HeFi-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4 patients experience dose-limiting toxicity. Patients are followed monthly. PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed CD30+ anaplastic large cell lymphoma (ALCL) or Hodgkin's lymphoma - At least 50% of malignant cells must react with HeFi-1 - HIV positive or HIV negative - Measurable disease - No symptomatic CNS disease - Must have failed or be ineligible for standard chemotherapy regimen PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Not specified Life expectancy: - More than 2 months Hematopoietic: - Not specified Hepatic: - No significant hepatic disease - Bilirubin no greater than 2 mg/dL Renal: - No significant renal disease - Creatinine no greater than 3 mg/dL Cardiovascular: - No significant cardiovascular disease Pulmonary: - No significant pulmonary disease Other: - No significant endocrine, rheumatologic, or allergic disease - No active clinical disease caused by cytomegalovirus (CMV), herpes simplex virus (HSV) I, HSV II, hepatitis B, or tuberculosis - Not pregnant - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior murine antibody therapy Chemotherapy: - See Disease Characteristics Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy to measurable disease Surgery: - Not specified Other - At least 4 weeks since prior cytotoxic therapy to measurable disease
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardJunghans, Study Chair, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Richard Junghans 617-432-7004
Additional Information:
Study ID Numbers: CDR0000066859; BIDMC-97127,NEDH-97127,NCI-870,NCI-V99-1515
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003741
Other Anaplastic Large Cell Lymphoma Studies:
1. Chemotherapy Plus Radiation Therapy in Treating Patients With Refractory or Relapsed Hodgkin's Lymphoma
2. MDX-060 Monoclonal Antibody in Treating Patients With Refractory or Relapsed Lymphoma
3. Vaccine Therapy in Treating Patients With Relapsed Hodgkin's Lymphoma
4. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Hodgkin's Lymphoma
5. Rituximab in Treating Patients With Hodgkin's Lymphoma
Related Studies:
Other anaplastic large cell lymphoma Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma
|
|
|
|
|
|
|
|
