Study of 90Y-hLL2 to Treat Non-Hodgkin's Lymphoma
This study has been terminated.
(lack of accrual)
Sponsor:
Immunomedics, Inc.
Information provided by:
Immunomedics, Inc.
ClinicalTrials.gov Identifier:
NCT00054834
First received: February 11, 2003
Last updated: January 8, 2008
Last verified: January 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkins Lymphoma |
Drug: hLL2 (epratuzumab) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Clinical Trial of Radiolabeled Immunotherapy With Humanized LL2 in Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma |
Resource links provided by NLM:
Further study details as provided by Immunomedics, Inc.:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054834
Locations
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States | |
Sponsors and Collaborators
Immunomedics, Inc.
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00054834 History of Changes |
| Other Study ID Numbers: | IM-T-hLL2-14 |
| Study First Received: | February 11, 2003 |
| Last Updated: | January 8, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013