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- Klinische proef 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
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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District of Columbia
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Washington, District of Columbia, Verenigde Staten, 20307-5000
- Walter Reed Army Medical Center
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55455
- University of Minnesota Cancer Center
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Missouri
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Saint Louis, Missouri, Verenigde Staten, 63110
- Washington University Barnard Cancer Center
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New Jersey
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Camden, New Jersey, Verenigde Staten, 08103
- Cooper Cancer Institute
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Paterson, New Jersey, Verenigde Staten, 07503
- St. Joseph's Hospital and Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: aminocamptothecin
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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
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Response
Tijdsspanne: 2 years post treatment
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2 years post treatment
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Toxicity
Tijdsspanne: day 1 of each cycle
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day 1 of each cycle
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9-AC/DMA concentrations
Tijdsspanne: Pre-treatment cycle 1 and just prior to completion of cycle 1
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Pre-treatment cycle 1 and just prior to completion of cycle 1
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Nancy L. Bartlett, MD, Washington University Siteman Cancer Center
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NCI-2012-02791
- U10CA031946 (Subsidie/contract van de Amerikaanse NIH)
- CLB-9551
- CDR0000064666 (Register-ID: PDQ (Physician Data Query))
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