- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00019227
Monoclonal Antibody Therapy in Treating Patients With Leukemia
PHASE I/II STUDY OF TAC-EXPRESSING ADULT T-CELL LEUKEMIA (ATL) WITH YTTRIUM-90 (90Y)-RADIOLABELED HUMANIZED ANTI-TAC AND CALCIUM-DTPA
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody plus pentetic acid calcium in patients with leukemia.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
- Determine the maximum tolerated dose of yttrium Y 90 daclizumab (90Y daclizumab) when combined with pentetic acid calcium in adults with Tac-expressing T-cell leukemia.
- Determine the therapeutic efficacy and toxicity of this regimen in these patients.
- Monitor patients treated on this regimen for circulating infused antibody (free and labeled) and for the serum concentration of soluble interleukin-2 receptor.
- Evaluate, in a preliminary manner, the immunogenicity of daclizumab.
- Determine the effect of 90Y daclizumab on various components of the circulating cellular immune system.
- Determine whether there is additional urinary excretion of yttrium Y 90 when compared to that observed previously in patients treated without pentetic acid calcium.
OUTLINE: This is a dose escalation study of yttrium Y 90 daclizumab (90Y daclizumab).
Patients receive 90Y daclizumab IV over 2 hours on day 1 and a fixed dose of pentetic acid calcium IV over 5 hours for 3 days. Treatment repeats every 6 weeks for a maximum of 9 courses in the absence of disease progression or circulating antibodies to humanized anti-Tac.
Cohorts of 3-6 patients receive escalating doses of 90Y daclizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Additional patients are treated at the MTD.
Patients are followed at 4-6 weeks.
PROJECTED ACCRUAL: Up to 15 patients will be accrued for the phase I portion of the study. A total of 30 patients will be accrued for the phase II portion of the study.
Undersøgelsestype
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiesteder
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Maryland
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Bethesda, Maryland, Forenede Stater, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
- Histologically confirmed adult T-cell leukemia or lymphoma (ATL) of any stage
Tac expression of malignant cells confirmed by one of the following:
- At least 10% of peripheral blood, lymph node, or dermal malignant cells reactive with anti-Tac by immunofluorescent staining
- Soluble interleukin-2 receptor levels greater than 1,000 U/mL (normal geometric mean = 235; 95% confidence intervals = 112-502 U/mL)
Measurable disease required
- More than 10% (i.e., strongly Tac-expressing) abnormal cells in peripheral blood considered measurable disease
All stages of Tac-expressing adult T-cell leukemia are eligible
Smoldering ATL patients are eligible only if the symptoms and sites of involvement by ATL are such that there is a medical indication to treat
Smoldering ATL, defined as:
- Lymphocyte count less than 4,000/mm^3
- Less than 5% abnormal lymphocytes on morphologic exam of peripheral blood
- No hypercalcemia
- Lactate dehydrogenase no greater than 1.5 times normal
- No lymphadenopathy
- No involvement of extranodal organs except skin or lung
- No malignant pleural effusion or ascites
No symptomatic CNS disease due to ATL
- Concurrent diagnosis of tropical spastic paraparesis allowed
- No detectable levels (i.e., greater than 250 ng/mL) of antibody to study drug as assessed by ELISA
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Not specified
Life expectancy:
- Greater than 2 months
Hematopoietic:
- Absolute granulocyte count at least 1,000/mm^3
- Platelet count at least 75,000/mm^3
Hepatic:
- Bilirubin less than 2.0 mg/dL (unless directly due to ATL)
- AST/ALT less than 2.5 times normal
Renal:
- Creatinine less than 1.5 mg/dL OR
- Creatinine clearance greater than 35 mL/min
Cardiovascular:
- No clinical cardiac failure
Pulmonary:
- No symptomatic pulmonary dysfunction unless due to underlying malignancy
Other:
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- At least 4 weeks since prior cytotoxic chemotherapy
Endocrine therapy
- Concurrent corticosteroids allowed
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- Not specified
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesygdomme
- Immunproliferative lidelser
- Leukæmi, lymfoid
- Leukæmi, T-celle
- Lymfom
- Leukæmi
- Leukæmi-lymfom, voksen T-celle
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Immunsuppressive midler
- Immunologiske faktorer
- Beskyttelsesagenter
- Calciumregulerende hormoner og midler
- Modgift
- Chelaterende midler
- Sekvesteringsagenter
- Jernchelateringsmidler
- Kalk
- Pentetic syre
- Daclizumab
Andre undersøgelses-id-numre
- CDR0000065240
- NCI-96-C-0147K
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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