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Radiolabeled Monoclonal Antibody With or Without Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Lymphoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Radiolabeled Monoclonal Antibody With or Without Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Lymphoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Radiolabeled Monoclonal Antibody With or Without Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Lymphoma Clinical research trials and Radiolabeled Monoclonal Antibody With or Without Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Lymphoma healthcare trials happen in a lot of of localities across 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 generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Radiolabeled Monoclonal Antibody With or Without Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Lymphoma. Radiolabeled Monoclonal Antibody With or Without Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Lymphoma Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Radiolabeled Monoclonal Antibody With or Without Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Lymphoma clinical trial. Human subjects often receive the most effective healthcare possible for their Radiolabeled Monoclonal Antibody With or Without Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Lymphoma condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiolabeled Monoclonal Antibody With or Without Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Lymphoma  Radiolabeled Monoclonal Antibody With or Without Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Lymphoma
Radiolabeled Monoclonal Antibody With or Without Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Lymphoma
For Condition: recurrent childhood lymphoblastic lymphoma,AIDS-related primary CNS lymphoma,AIDS-related peripheral/systemic lymphoma,recurrent childhood large cell lymphoma,recurrent childhood small noncleaved cell lymphoma,recurrent/refractory childhood Hodgkin's lymphoma
Status: Recruiting
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Radiolabeledmonoclonal antibodies can locate cancer cells and deliver radioactive tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by anticancer therapy. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy with or without peripheral stem cell transplantation in treating patients who have recurrent or refractorylymphoma.
Details: OBJECTIVES: - Determine the maximum tolerated dose (MTD) of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8) when preceded by rituximab in children with recurrent or refractory CD20-positive lymphoma for which no autologous peripheral blood stem cell transplantation (AuPBSCT) is planned. (Group A) - If the dose-limiting toxicity (DLT) in group A is purely hematological, determine the MTD of IDEC-Y2B8 when combined with rituximab, AuPBSCT, and filgrastim (G-CSF) in a second group of children with recurrent or refractory CD20-positive lymphoma. (Group B) - Determine the DLT of rituximab and IDEC-Y2B8 in these patients. - Determine the dosimetry of indium In 111 ibritumomab tiuxetan preceded by rituximab in these patients. - Determine, preliminarily, the antitumor activity of rituximab and IDEC-Y2B8 in these patients. - Assess the immune cell depletion (B-cell and T-cell) and recovery in patients treated with this regimen. - Determine the human anti-mouse antibody response in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8). Patients are assigned to 1 of 2 groups. - Patients receive rituximab IV over 4-6 hours followed by indium In 111 ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0 and undergo whole body imaging. Patients may then receive rituximab IV over 4-6 hours followed by IDEC-Y2B8 IV over 10 minutes on day 7. Cohorts of 3-6 patients in each subgroup (A1, A2, and A3) receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT). Some patients receive autologous PBSC IV over 30-60 minutes on day 35. - Patients receive rituximab, IDEC-In2B8, and IDEC-Y2B8 as in group A. Patients also receive autologous PBSC IV over 30-60 minutes on day 21 and filgrastim (G-CSF) subcutaneously beginning on day 22 and continuing until blood counts recover or day 35. If the DLT in group A is purely hematological, cohorts of 3-6 patients in group B receive escalating doses of IDEC-Y2B8 until the MTD is determined. The MTD is defined as in group A. Patients in both groups are followed at days 63, 90, 180, 365, and then annually thereafter. PROJECTED ACCRUAL: A maximum of 100 patients will be accrued for this study within 3.3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed and immunophenotypically (CD20)-positive lymphoma at original diagnosis, progression, or relapse - Refractory to conventional therapy - First recurrent/refractory CD20-positive non-Hodgkin's lymphoma (NHL) allowed if ineligible for or refused regimens with known curative potential (high-dose chemotherapy plus bone marrow transplantation) (if available) - Second or third progression and/or recurrence of NHL - Second or third relapse/refractory CD20-positive Hodgkin's lymphoma - CD20-positive, post-transplantation lymphoproliferative lymphoma that is medically refractory (decreased immunosuppression) to rituximab and/or chemotherapy - Medically refractory, HIV-associated, CD20-positive NHL - Recurrent/refractory CD20-positive lymphoblastic lymphoma - Autologous peripheral blood stem cells (PBSC) collected, selected for a minimum of 2 x 10^6 CD34-positive cells per kg, and cryopreserved before study - Good marrow reserve, defined by both of the following: - No prior myeloablative stem cell transplantation (SCT) - No prior extensive radiotherapy, defined by any of the following: - Prior total body irradiation - Prior radiotherapy dose of 3,600 cGy or more to cranio-spinal axis - Prior radiotherapy to 50% or more of bone marrow OR - Poor marrow reserve, defined by either or both of the following: - Prior myeloablative SCT - Prior extensive radiotherapy PATIENT CHARACTERISTICS: Age: - Under 22 Performance status: - Lansky 50-100% (age 10 and under) - Karnofsky 50-100% (age 11 to 21) Life expectancy: - At least 2 months Hematopoietic: - See Biologic therapy - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 for good marrow reserve (150,000/mm^3 for poor marrow reserve) - Hemoglobin at least 8.0 g/dL (RBC transfusion allowed) Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - ALT no greater than 5 times ULN - Albumin at least 2 g/dL Renal: - Creatinine normal OR - Creatinine clearance or glomerular filtration rate at least 70 mL/min Cardiovascular: - Shortening fraction at least 27% by echocardiogram OR - Ejection fraction at least 50% by MUGA Pulmonary: - No dyspnea at rest - No exercise intolerance - Oxygen saturation (SpO_2) more than 94% by pulse oximetry (if there is a clinical indication for SpO_2 assessment) Other: - Not pregnant or nursing - Negative pregnancy test - No documented infection that is unresponsive to appropriate antibiotic, antiviral, or antifungal therapy - No grade 2 or greater CNS toxicity - Seizure disorder allowed if well controlled and on anticonvulsants PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - Recovered from prior immunotherapy - At least 1 week since prior antineoplastic biologic agents - Prior SCT allowed if the following criteria are met: - At least 60 days since prior SCT - Full hematopoietic reconstitution post-SCT - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 (transfusion independent) - Hemoglobin at least 8.0 g/dL (RBC transfusion allowed) - No evidence of active acute or chronic graft-versus-host disease if post- allogeneic SCT - No concurrent sargramostim (GM-CSF) Chemotherapy: - See Disease Characteristics - At least 3 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosourea) and recovered Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - Recovered from prior radiotherapy Surgery: - Not specified Other: - No concurrent medications that would interact with the study drug
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MitchellCairo, Study Chair, Columbia University
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Children's Hospital and Regional Medical Center - Seattle *Recruiting*
Seattle, Washington, 98105
United States
Recruiting John Holcenberg 206-987-2106
MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Jill Gilbert 504-568-5136
St. Jude Children's Research Hospital *Recruiting*
Memphis, Tennessee, 38105-2794
United States
Recruiting Wayne Furman 901-495-3300
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting Dale Pullen 601-984-5220
Texas Children's Cancer Center *Recruiting*
Houston, Texas, 77030-2399
United States
Recruiting Susan Blaney 832-822-4215
CCOP - Columbia River Oncology Program *Recruiting*
Portland, Oregon, 97225
United States
Recruiting Keith Lanier 503-216-6260
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Carola Arndt 507-284-4822
Children's Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Regina Jakacki 412-692-5055
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Mitchell Cairo 212-305-8316
Hopital Sainte Justine *Recruiting*
Montreal, Quebec, H3T 1C5
Canada
Recruiting Mark Bernstein 514-345-4969
Hospital for Sick Children *Recruiting*
Toronto, Ontario, M5G 1X8
Canada
Recruiting Sylvain Baruchel 416-813-7795
Lucile Packard Children's Hospital at Stanford University Medical Center *Recruiting*
Palo Alto, California, 94304
United States
Recruiting Gary Houten Dahl 650-497-8238
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting James Croop 317-278-4822
Children's National Medical Center *Recruiting*
Washington D.C., District of Columbia, 20010-2916
United States
Recruiting Anne Angiolillo 202-884-2800
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Brenda Weigel 612-626-8484
Doernbecher Children's Hospital at Oregon Health & Science University *Recruiting*
Portland, Oregon, 97239-3098
United States
Recruiting H. Nicholson 503-494-1543
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
Cincinnati Children's Hospital Medical Center *Recruiting*
Cincinnati, Ohio, 45229-2899
United States
Recruiting Robert Wells 513-636-4200
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390-9063
United States
Recruiting Naomi Winick 214-648-3074
Children's Hospital Los Angeles *Recruiting*
Los Angeles, California, 90027-0700
United States
Recruiting Paul Gaynon 323-669-2163
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Holcombe Grier 617-632-3971
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104-4318
United States
Recruiting Peter Adamson 215-590-5448
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Ronald Dubowy 315-464-5294
Additional Information:
Study ID Numbers: CDR0000069331; COG-ADVL0013
Study Start Date:
Record last reviewed: November 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036855
Other Aids-Related Peripheral/systemic Lymphoma Studies:
1. 506U78 in Treating Patients With Refractory Hematologic Cancer
2. Sirolimus in Treating Young Patients With Relapsed or Refractory Acute Leukemia or Non-Hodgkin's Lymphoma
3. Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors
4. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Hodgkin's or Non-Hodgkin's Lymphoma
5. Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia, Osteosarcoma, or Non-Hodgkin's Lymphoma
Related Studies:
Other AIDS-related peripheral/systemic lymphoma Clinical Trials
Other Texas Clinical Trials
Other Temple Clinical Trials
Radiolabeled Monoclonal Antibody With or Without Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Lymphoma
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