Lymphoma
A Phase I/II Study of Tac-Expressing Malignancies (Other than ATL) with Yttrium-90 (90Y)-Radiolabeled Humanized Anti-Tac and Calcium-DTPA
NCI-97-C-0110, NCT00019305
Print this page
Investigator(s): |
Thomas Waldmann, M.D. Principal Investigator Phone: 301-496-6656 Fax: 301-496-9956 tawald@mail.nih.gov
|
|
|
|
Tat’Yana Worthy, R.N. Research Nurse Specialist Phone: 301-496-0499 worthyt@mail.nih.gov
|
|
|
|
Key Eligibility Criteria:
- Hodgkin’s lymphoma: stages II-IV that relapsed or failed to achieve complete remission after first line chemotherapy, and not eligible for or refused salvage chemotherapy or bone marrow transplantation
- No chronic anticoagulant therapy
- Karnofsky 50–100%
- Granulocyte count at least 1,200/mm³, platelet count greater than 100,000/mm³
- SGOT and SGPT less than 5 times upper limit of normal (ULN), bilirubin less than 3 times ULN
- Creatinine less than 2.0 mg/dL OR creatinine clearance greater than 50 mL/min
- No clinical evidence of cardiac failure
- No symptomatic pulmonary dysfunction unless due to malignancy
- Previous bone marrow transplant is allowed
Study Outline:
Patients are given yttrium (Y 90) labeled humanized anti-Tac monoclonal antibody (Y-HAT) with a fixed dose of Calcium-DTPA (Ca-DTPA) and Indium In 111 labeled humanized anti-Tac monoclonal antibody.
- Day 1, Y-HAT and In-HAT are administered intravenously (IV) over 2 hours followed by a 5 hour infusion of Ca-DTPA
- Days 2 and 3, additional 5 hour infusions of Ca-DTPA are given
- Day 42–70, the treatment course may be repeated at the same dosage level
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 9/12/12
Updated: 2/7/12