- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00019656
Perifosine in Treating Patients With Refractory Solid Tumors or Hematologic Cancer
A Phase I Trial of Oral Perifosine With Different Loading Schedules in Patients With Refractory Neoplasms
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of perifosine in treating patients who have refractory solid tumors or hematologic cancer.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
- Determine the dose-limiting toxicity and maximum tolerated dose of perifosine administered as a varying series of loading and maintenance doses in patients with refractory solid tumors, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, myelodysplastic syndromes, or Hodgkin's lymphoma.
- Determine the profile of adverse reactions (including changes in laboratory parameters) in patients treated with this regimen.
- Determine any disease responses that may occur in patients treated with this regimen.
- Determine the steady-state pharmacology and pharmacokinetics of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive a loading dose of oral perifosine on day 1 followed by a maintenance dose 2-3 times daily beginning on day 2 or 3 and continuing until day 21. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating loading and maintenance doses of perifosine until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 10 patients are treated at that dose level.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 12-18 months.
Studietype
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Maryland
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Bethesda, Maryland, Forente stater, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
-
Bethesda, Maryland, Forente stater, 20892
- NCI - Center for Cancer Research
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
- Histologically confirmed solid tumor, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, myelodysplastic syndromes, or Hodgkin's lymphoma that has no effective standard therapeutic option but requires systemic therapy
- No history of CNS neoplasms
For prostate cancer:
- Tumor progression during blockade of testicular and adrenal androgens
- At least 4 weeks since prior flutamide or other antiandrogens without disease improvement
- Leuprolide or other gonadotropin-releasing hormones should be maintained in patients without an orchiectomy
- Testosterone in the castrate range
For breast cancer:
- At least 4 weeks since any prior hormonal therapy with evidence of disease progression
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count greater than 50,000/mm^3
- Absolute granulocyte count greater than 500/mm^3
- Hemoglobin at least 9.0 g/dL
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- SGOT and SGPT no greater than 2.5 times normal
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No history of unstable or newly diagnosed angina pectoris
- No myocardial infarction within the past 6 months
- No New York Heart Association class II-IV heart disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No recent acute or chronic gastrointestinal conditions (e.g., stomach ulcer or enteritis) that might affect tolerability or drug absorption
- No allergic reaction to any medication with a structure similar to perifosine
- No pre-existing retinal disease or pathologic baseline electrooculogram
- No cataracts that would interfere with normal vision or require medical intervention
- No other serious concurrent illness that would preclude assessment of drug effect
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- At least 2 months since prior UCN-01
- More than 3 months since prior suramin
Endocrine therapy:
- See Disease Characteristics
- No concurrent corticosteroids except for physiological replacement or as antiemetics
Radiotherapy:
- At least 4 weeks since prior radiotherapy (6 weeks for bone-seeking radioisotopes) and recovered
Surgery:
- See Disease Characteristics
Other:
- No other concurrent antineoplastic therapies
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Edward A. Sausville, MD, PhD, National Cancer Institute (NCI)
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Monga M, Messmann RA, Headlee D, et al.: A phase I trial of oral perifosine in patients with refractory neoplasms. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1837, 7b, 2002.
- Messmann RA, Headlee D, Woo EW, et al.: A phase I trial of oral perifosine with different loading and maintenance schedules in patients with refractory neoplasms. [Abstract] Proc Am Assoc Cancer Res 42: A-2880, 2001.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- uspesifisert voksen solid svulst, protokollspesifikk
- stadium IV grad 3 follikulært lymfom
- stadium IV voksent diffust storcellet lymfom
- stadium IV voksent immunoblastisk storcellet lymfom
- stadium IV voksen Burkitt lymfom
- tilbakevendende grad 3 follikulær lymfom
- tilbakevendende voksent diffust storcellet lymfom
- tilbakevendende immunoblastisk storcellet lymfom hos voksne
- tilbakevendende voksen Burkitt lymfom
- kronisk myelomonocytisk leukemi
- de novo myelodysplastiske syndromer
- tidligere behandlede myelodysplastiske syndromer
- sekundære myelodysplastiske syndromer
- tilbakevendende voksen Hodgkin lymfom
- tilbakevendende voksent diffust små spaltet celle lymfom
- tilbakevendende voksent diffust blandet celle lymfom
- stadium IV grad 1 follikulær lymfom
- stadium IV grad 2 follikulært lymfom
- stadium IV voksent diffust små spaltet celle lymfom
- stadium IV voksent diffust blandet celle lymfom
- stadium IV mantelcellelymfom
- tilbakevendende grad 1 follikulær lymfom
- tilbakevendende grad 2 follikulær lymfom
- tilbakevendende marginalsone lymfom
- tilbakevendende små lymfatiske lymfomer
- stadium IV små lymfatiske lymfomer
- stadium IV marginal sone lymfom
- ekstranodal marginalsone B-celle lymfom av slimhinneassosiert lymfoidvev
- nodal marginal sone B-celle lymfom
- milt marginal sone lymfom
- tilbakevendende lymfoblastisk lymfom hos voksne
- tilbakevendende mantelcellelymfom
- refraktær kronisk lymfatisk leukemi
- stadium IV kronisk lymfatisk leukemi
- stadium IV voksen Hodgkin lymfom
- stadium IV voksen lymfatisk lymfom
- myelodysplastisk/myeloproliferativ neoplasma, ikke klassifiserbar
- atypisk kronisk myeloid leukemi, BCR-ABL1 negativ
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Lymfoproliferative lidelser
- Lymfesykdommer
- Immunproliferative lidelser
- Sykdom
- Benmargssykdommer
- Hematologiske sykdommer
- Forstadier til kreft
- Neoplasmer
- Lymfom
- Syndrom
- Myelodysplastiske syndromer
- Leukemi
- Preleukemi
- Myeloproliferative lidelser
- Myelodysplastiske-myeloproliferative sykdommer
Andre studie-ID-numre
- CDR0000066960
- NCI-99-C-0043
- NCI-T98-0065
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