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- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Contacten en locaties
Studie Locaties
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Maryland
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Bethesda, Maryland, Verenigde Staten, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Bethesda, Maryland, Verenigde Staten, 20892
- NCI - Center for Cancer Research
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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 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Edward A. Sausville, MD, PhD, National Cancer Institute (NCI)
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
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
- niet-gespecificeerde volwassen solide tumor, protocolspecifiek
- stadium IV graad 3 folliculair lymfoom
- stadium IV volwassen diffuus grootcellig lymfoom
- stadium IV volwassen immunoblastisch grootcellig lymfoom
- stadium IV volwassen Burkitt-lymfoom
- recidiverend graad 3 folliculair lymfoom
- recidiverend diffuus grootcellig lymfoom bij volwassenen
- recidiverend volwassen immunoblastisch grootcellig lymfoom
- recidiverend volwassen Burkitt-lymfoom
- chronische myelomonocytaire leukemie
- de novo myelodysplastische syndromen
- eerder behandelde myelodysplastische syndromen
- secundaire myelodysplastische syndromen
- recidiverend volwassen Hodgkin-lymfoom
- recidiverend diffuus kleincellig lymfoom bij volwassenen
- recidiverend diffuus gemengd cellymfoom bij volwassenen
- stadium IV graad 1 folliculair lymfoom
- stadium IV graad 2 folliculair lymfoom
- stadium IV volwassen diffuus klein-gesplitst cellymfoom
- stadium IV volwassen diffuus gemengd cellymfoom
- stadium IV mantelcellymfoom
- recidiverend graad 1 folliculair lymfoom
- recidiverend graad 2 folliculair lymfoom
- recidiverend marginale zone-lymfoom
- terugkerend klein lymfocytisch lymfoom
- stadium IV klein lymfocytisch lymfoom
- stadium IV marginale zone lymfoom
- extranodale marginale zone B-cellymfoom van mucosa-geassocieerd lymfoïde weefsel
- nodale marginale zone B-cellymfoom
- milt marginale zone lymfoom
- recidiverend volwassen lymfoblastisch lymfoom
- terugkerend mantelcellymfoom
- refractaire chronische lymfatische leukemie
- stadium IV chronische lymfatische leukemie
- stadium IV volwassen Hodgkin-lymfoom
- stadium IV volwassen lymfoblastisch lymfoom
- myelodysplastisch/myeloproliferatief neoplasma, niet te classificeren
- atypische chronische myeloïde leukemie, BCR-ABL1 negatief
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Lymfoproliferatieve aandoeningen
- Lymfatische ziekten
- Immunoproliferatieve aandoeningen
- Ziekte
- Beenmergziekten
- Hematologische ziekten
- Voorstadia van kanker
- Neoplasmata
- Lymfoom
- Syndroom
- Myelodysplastische syndromen
- Leukemie
- Preleukemie
- Myeloproliferatieve aandoeningen
- Myelodysplastische-myeloproliferatieve ziekten
Andere studie-ID-nummers
- CDR0000066960
- NCI-99-C-0043
- NCI-T98-0065
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