- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00041327
Combination Chemotherapy Followed By Antiviral Therapy and Interferon Alfa in Treating Patients With HTLV-1-Related Adult T-Cell Leukemia/Lymphoma
Phase II Trial Of Induction Therapy With EPOCH Chemotherapy And Maintenance Therapy With Combivir/Interferon ALPHA-2a For HTLV-1 Associated T-Cell Non-Hodgkin's Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Antiviral therapy may kill viruses such as HTLV-1 that can cause cancer. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with antiviral drugs and interferon alfa may be effective in treating adult T-cell leukemia/lymphoma.
PURPOSE: Phase II trial to determine the effectiveness of combination chemotherapy followed by antiviral therapy and interferon alfa in treating patients who have adult T-cell leukemia/lymphoma caused by HTLV-1.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
OBJECTIVES:
- Determine the efficacy of etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (EPOCH) followed by lamivudine, zidovudine, and interferon alfa, in terms of response rate, in patients with HTLV-1-associated adult T-cell leukemia/lymphoma.
- Determine the duration of response in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the effect of this regimen on markers of virus replication and expression and immune function in these patients.
OUTLINE: This is a multicenter study.
Patients receive EPOCH chemotherapy comprising etoposide, vincristine, and doxorubicin IV continuously on days 1-5, cyclophosphamide IV over 30 minutes on day 5, and oral prednisone on days 1-5. Patients also receive filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 7 and continuing until blood counts recover. Treatment repeats every 21-28 days for at least 2 courses beyond best response or for up to 6 courses in the absence of unacceptable toxicity, disease progression, or stable disease.
Beginning 1 month after completion of EPOCH, patients receive oral lamivudine and zidovudine twice daily and interferon alfa SC daily continuously for 1 year.
Patients are followed monthly for 1 year, every 2 months for 1 year, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 10-32 patients will be accrued for this study within 1-2 years.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
California
-
Los Angeles, California, Förenta staterna, 90089-9181
- USC/Norris Comprehensive Cancer Center and Hospital
-
-
Florida
-
Miami, Florida, Förenta staterna, 33136
- University of Miami Sylvester Comprehensive Cancer Center
-
-
Missouri
-
Saint Louis, Missouri, Förenta staterna, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed HTLV-1-associated adult T-cell leukemia/lymphoma (ATLL)
- Previously treated ATLL allowed
- CD3-positive
- Documented HTLV-1 infection by serologic assay (ELISA, Western blot)
- Measurable or evaluable disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 50-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count greater than 1,000/mm^3*
- Platelet count greater than 75,000/mm^3* NOTE: *Unless cytopenia is secondary to ATLL
Hepatic:
- Transaminase less than 7 times upper limit of normal
- Bilirubin less than 2.0 mg/dL (unless secondary to hepatic infiltration with lymphoma or isolated indirect hyperbilirubinemia associated with indinavir)
Renal:
- Creatinine less than 2.0 mg/dL (unless due to lymphoma)
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study completion
- No active opportunistic infection requiring acute therapy
- No untreated thyroid disease
- No autoimmune disease
- No uncontrolled significant psychiatric disease
- No other concurrent malignancy except carcinoma in situ of the cervix or non-metastatic nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 24 hours since prior hematologic growth factors
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- Concurrent chronic therapy with potentially myelosuppressive agents allowed
- Other concurrent antiretroviral therapy for HIV, hepatitis B, or hepatitis C infection (or other indication) allowed at investigator's discretion for patients receiving therapy prior to study initiation
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Varaktighet för svar
Tidsram: 3 år
|
3 år
|
|
Giftighet
Tidsram: 1 år
|
1 år
|
|
Efficacy
Tidsram: 60 days
|
60 days
|
|
Effects on markers of virus replication and expression and immune function
Tidsram: 5 years
|
5 years
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studiestol: Lee Ratner, MD, PhD, Washington University Siteman Cancer Center
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Lymfoproliferativa störningar
- Lymfatiska sjukdomar
- Immunproliferativa störningar
- Leukemi, lymfoid
- Leukemi
- Lymfom
- Leukemi, T-cell
- Leukemi-lymfom, vuxen T-cell
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Omvända transkriptashämmare
- Nukleinsyrasynteshämmare
- Enzyminhibitorer
- Anti-HIV-medel
- Antiretrovirala medel
- Antiinflammatoriska medel
- Antireumatiska medel
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitut och hormonantagonister
- Antineoplastiska medel, hormonella
- Antineoplastiska medel, Alkylering
- Alkyleringsmedel
- Myeloablativa agonister
- Antineoplastiska medel, fytogena
- Topoisomeras II-hämmare
- Topoisomerasinhibitorer
- Antibiotika, antineoplastiska
- Interferoner
- Interferon-alfa
- Cyklofosfamid
- Etoposid
- Prednison
- Lamivudin
- Zidovudin
- Doxorubicin
- Liposomal doxorubicin
- Vincristine
Andra studie-ID-nummer
- AMC-033
- U01CA070019 (U.S.S. NIH-anslag/kontrakt)
- CDR0000069469 (Annan identifierare: NCI)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .