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Study of 90Y-hLL2 to Treat Non-Hodgkin's Lymphoma



Study of 90Y-hLL2 to Treat Non-Hodgkin's Lymphoma

For Condition: Non-Hodgkins Lymphoma
Status: Not yet recruiting
Sponsor(s): Immunomedics, Inc. ,
Synopsis: The purpose of this trial is to determine the safety of 90Y-hLL2 at different dose levels in the treatment of Non-Hodgkin's lymphoma.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Disease Characteristics: - Patients with a documented histologic or cytologic diagnosis of B-cell NHL. - Patients who have failed at least one regimen of chemotherapy and are not eligible for any alternate therapies of higher therapeutic priority. - Patients with at least one measurable tumor site > 1.5 cm in at least one dimension. Prior/Concurrent Therapy: - Chemotherapy: Patients must have failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority. - Biologic Therapy: Patients who have received human or humanized monoclonal antibodies will be eligible provided pre-study evaluations demonstrate no significant reactivity with hLL2 IgG (i.e., HAHA). - Radiotherapy: No prior radiation therapy to >25% of the bone marrow. No prior radiation to maximal tolerable levels for any critical organ (e.g., 2,000 cGy for the lungs and kidneys). Patients who have had whole pelvic irradiation are not eligible. Patient Characteristics/Inclusion Criteria: - Age Range: Male or Female at least 18 years of age - Performance Status: Patients with a Karnofsky performance status > 60% (or equivalent, ECOG 0-2) and expected survival of at least 12 weeks. - Hematopoietic: Hemoglobin > 10 g/dL; ANC > 1.5x10^9/L; Platelets > 100x10^9/L; - Hepatic: Serum bilirubin < 2.0 mg/dL; AST and ALT < 2 x ULN w/o liver metastases or <5 x ULN w/liver metastases - Renal: Creatinine < 2.0 mg/dL - Cardiovascular: Patients with LVEF >/= 50% by MUGA or 2D-ECHO. - Pulmonary: Patients with DFCO and FEV1 >/= 60% by required Pulmonary Function Tests. - Other: Patients agreeing to use a medically effective method of contraception while enrolled in the study. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the study. Patients able to understand and give written informed consent.
Total Enrollment: 27

Location and Contact Information:

Fox Chase Cancer Center
Philadelphia,  Pennsylvania, 
United States
 

MD Anderson Cancer Center
Houston,  Texas, 
United States
 


Additional Information:
Study ID Numbers:  IM-T-hLL2-14; 
Study Start Date: March 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054834

Other Non-Hodgkins Lymphoma Studies:
1. Study of 90Y-hLL2 to Treat Non-Hodgkin's Lymphoma

2. Phase I/II Study of CAMPATH in Patients with Relapsing or Refractory Non-Hodgkin’s Lymphoma

3. Giving Gene Marked(Optional) Epstein Barr Virus (EBV) Specific Cytotoxic T-Cells to Patients with Relapsed EBV-Positive Lymphoma,

4. Giving Gene Marked Epstein Barr Virus (EBV) Specific T-Cells to Patients Receiving a Bone Marrow Transplant (BMT) for Relapsed EBV-Positive Hodgkin Disease

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