- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00002745
Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma
PHASE II STUDY OF 9-AMINOCAMPTOTHECIN (9-AC/DMA, NSC# 603071) IN PREVIOUSLY TREATED HODGKIN'S DISEASE AND NON-HODGKIN'S LYMPHOMA: IWF GRADES A-H
Studieöversikt
Detaljerad beskrivning
OBJECTIVES:
I. Evaluate the response rate and duration of response to aminocamptothecin (9-AC) in patients with refractory or relapsed Hodgkin's disease or non-Hodgkin's lymphoma.
II. Assess the toxicity of 9-AC in these patients. III. Validate a preliminary pharmacodynamic model relating total 9-AC concentration, albumin, and bilirubin to toxicity.
IV. Determine whether 9-AC concentrations correlate with response.
OUTLINE: Patients are stratified by disease histology (International Working Formulation (IWF) A-C vs IWF D-F) and center.
Patients receive aminocamptothecin IV continuously on days 1-3. Treatment repeats every 2 weeks for a minimum of 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease, partial response (PR), or complete response (CR) may receive 2 additional courses past best response (minimum of 6 courses if PR or CR). Patients are followed every 6 months for 2 years, and then annually thereafter.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
District of Columbia
-
Washington, District of Columbia, Förenta staterna, 20307-5000
- Walter Reed Army Medical Center
-
-
Minnesota
-
Minneapolis, Minnesota, Förenta staterna, 55455
- University of Minnesota Cancer Center
-
-
Missouri
-
Saint Louis, Missouri, Förenta staterna, 63110
- Washington University Barnard Cancer Center
-
-
New Jersey
-
Camden, New Jersey, Förenta staterna, 08103
- Cooper Cancer Institute
-
Paterson, New Jersey, Förenta staterna, 07503
- St. Joseph's Hospital and Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
- Histologically documented Hodgkin's disease (closed to accrual 4/15/2000) OR
Histologically documented non-Hodgkin's lymphoma (NHL) of one of the following International Working Formulation (IWF) histologies:
- Small lymphocytic (absolute lymphocyte count less than 5,000)
- IWF A Follicular, predominantly small cleaved cell
- IWF B Follicular mixed
- IWF C Follicular large cell
- IWF D* Diffuse small cleaved cell
- IWF E* Diffuse mixed
- IWF F* Diffuse large cell
- IWF G* Large cell, immunoblastic
- IWF H* * Accrual of patients with these diagnoses closed 4/15/2000
- Pathology review required within 60 days of registration
Refractory to or relapsed after prior chemotherapy as follows:
- Low-grade NHL (IWF A-C): 1 or 2 prior therapies
- Intermediate-grade NHL (IWF D-H): 1 prior therapy (stratum closed 4/15/2000)
- Hodgkin's disease: 1 or 2 prior therapies (stratum closed 4/15/2000)
- Treatment with the same drugs on 2 different schedules considered 1 therapy
- Measurable disease by physical exam or imaging studies
- Mass larger than 1 x 1 cm
- Documented progression required of previously irradiated lesions
The following are not considered measurable:
- Ascites or pleural effusion
- Bone marrow involvement
- Positive barium studies
- Bony disease (lytic lesions noted)
- No mantle cell or transformed lymphoma
- No parenchymal or leptomeningeal CNS disease
- A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
- Age: 18 and over
- Performance status: CALGB 0-2
Unless hypersplenism or biopsy-proven bone marrow involvement:
- Absolute granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Bilirubin normal
- AST no greater than 4 times normal
- Creatinine normal
- No suspected HIV infection
No second malignancy within past 5 years except:
- Curatively treated carcinoma of the cervix
- Curatively treated basal cell skin cancer
- No uncontrolled infection or other serious medical condition
- No psychiatric condition that precludes informed consent
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- No prior allogeneic or autologous bone marrow transplant
- More than 3 weeks since chemotherapy (6 weeks since nitrosoureas, melphalan, or mitomycin)
- No prior camptothecin
- More than 3 weeks since radiotherapy
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: aminocamptothecin
|
850 micrograms/square meter/day (total dose 2550 micrograms/square meter) via central venous catheter using infusion pump over 72 hours + one cycle Cycle repeated every 14 days for minimum of 6 cycles if partial or complete response
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Response
Tidsram: 2 years post treatment
|
2 years post treatment
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Toxicity
Tidsram: day 1 of each cycle
|
day 1 of each cycle
|
9-AC/DMA concentrations
Tidsram: Pre-treatment cycle 1 and just prior to completion of cycle 1
|
Pre-treatment cycle 1 and just prior to completion of cycle 1
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Nancy L. Bartlett, MD, 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
Andra studie-ID-nummer
- NCI-2012-02791
- U10CA031946 (U.S.S. NIH-anslag/kontrakt)
- CLB-9551
- CDR0000064666 (Registeridentifierare: PDQ (Physician Data Query))
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 .
Kliniska prövningar på aminocamptothecin
-
Emory UniversityNational Cancer Institute (NCI)AvslutadNjurcancerFörenta staterna
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)AvslutadLungcancerFörenta staterna
-
NYU Langone HealthNational Cancer Institute (NCI); Eastern Cooperative Oncology GroupAvslutadÄggstockscancerFörenta staterna
-
University of ChicagoNational Cancer Institute (NCI)AvslutadMagcancer | MatstrupscancerFörenta staterna
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)AvslutadÄggstockscancer | Primär peritonealcancerFörenta staterna, Kanada
-
Dana-Farber Cancer InstituteMassachusetts General Hospital; Beth Israel Deaconess Medical Center; Brigham...AvslutadAkut lymfatisk leukemi | Leukemi, Myelocytisk, AkutFörenta staterna
-
NYU Langone HealthNational Cancer Institute (NCI)AvslutadCancerFörenta staterna
-
Yale UniversityNational Cancer Institute (NCI)Avslutad