Leukemia, T-CellPhase 1NCT00001249
Treatment of Tac-Expressing Cutaneous T-Cell Lymphoma (CTCL) and Adult T-Cell Leukemia (ATL) With Yttrium-90 Radiolabeled Anti-Tac
A Phase 1 study testing Yttrium-90 radiolabeled anti-Tac antibody in people with Leukemia, T-Cell and Lymphoma, T-Cell, Cutaneous, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
The study purpose is to evaluate the clinical response to multidose administration of anti-Tac monoclonal antibody conjugated with 10 mCi 90Y in patients with Tac-expressing adult T-cell leukemia (ATL). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leukemia, T-Cell, Lymphoma, T-Cell, Cutaneous
- What is being tested?
- Yttrium-90 radiolabeled anti-Tac antibody
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1989to Oct 2000
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
Histologically confirmed adult T-cell leukemia/lymphoma (ATL) or cutaneous T-cell lymphoma (CTCL).
Reactivity of at least 10% of peripheral blood, lymph node, or dermal malignant cells with anti-Tac as determined by immunofluorescent staining or soluble IL-2 receptor level greater than 1,500 U required.
All stages of Tac-expressing T-cell leukemia and lymphoma eligible except Stage I CTCL.
All forms of ATL eligible, including the "smoldering" type as well as aggressive disease.
No symptomatic CNS disease other than tropical spastic paraparesis.
Asymptomatic CNS disease with demonstrable malignant cells in the CSF allowed (such patients receive CNS therapy, e.g., intrathecal methotrexate and/or CNS irradiation, as appropriate).
PRIOR/CONCURRENT THERAPY:
Biologic Therapy: Not specified.
Chemotherapy:
CTCL must have failed initial chemotherapy.
ATL may or may not have had prior chemotherapy.
At least 4 weeks since prior cytotoxic chemotherapy.
Endocrine Therapy: Not specified.
Radiotherapy: At least 4 weeks since prior radiotherapy.
Surgery: Not specified.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Performance status: Not specified.
Life expectancy: Greater than 1 month.
Hematopoietic: WBC at least 3,000, Platelets at least 75,000.
Hepatic: Not specified.
Renal: Not specified.
Other:
No pregnant women.
Negative pregnancy test required of fertile women.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
The study purpose is to evaluate the clinical response to multidose administration of anti-Tac monoclonal antibody conjugated with 10 mCi 90Y in patients with Tac-expressing adult T-cell leukemia (ATL).
Read the detailed description
The study purpose is to evaluate the clinical response to multidose administration of anti-Tac monoclonal antibody conjugated with 10 mCi 90Y in patients with Tac-expressing adult T-cell leukemia (ATL). This study represents an extension of phase I trial (Clinical Project #90-C-0043, FDA IND #3469) which permitted the administration of 5 mCi, 10 mCi, and 15mCi 90Y-anti-Tac to patients with ATL. We propose to administer 90Y-anti-Tac (10 mCi doses) to patients with Tac-expressing ATL who are over 18 years of age and who fill the patient eligibility criteria.
- Conditions
- Leukemia, T-Cell, Lymphoma, T-Cell, Cutaneous
- Being tested
- Yttrium-90 radiolabeled anti-Tac antibody
- Keywords
- Interleukin-2 Receptor
- Medical subject headings
- Leukemia, T-Cell, Lymphoma, T-Cell, Cutaneous, Diabetes Mellitus, Insulin-Dependent, 10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yttrium-90 radiolabeled anti-Tac antibodyDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startDec 1989
- Study completionOct 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Leukemia, T-CellStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001249
- Sponsor's protocol ID
- 900043
- Other IDs
- 90-C-0043
- Status last verified
- Nov 1999
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Waldmann TA, Goldman CK, Bongiovanni KF, Sharrow SO, Davey MP, Cease KB, Greenberg SJ, Longo DL. Therapy of patients with human T-cell lymphotrophic virus I-induced adult T-cell leukemia with anti-Tac, a monoclonal antibody to the receptor for interleukin-2. Blood. 1988 Nov;72(5):1805-16.
PubMed 2846094Kozak RW, Raubitschek A, Mirzadeh S, Brechbiel MW, Junghans RP, Gansow OA, Waldmann TA. Nature of the bifunctional chelating agent used for radioimmunotherapy with yttrium-90 monoclonal antibodies: critical factors in determining in vivo survival and organ toxicity. Cancer Res. 1989 May 15;49(10):2639-44.
PubMed 2785435