- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00003850
Thalidomide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
A Phase II Study of Thalidomide in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck
Studieoversigt
Detaljeret beskrivelse
OBJECTIVES:
I. Determine the effect of thalidomide on survival of patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
II. Determine clinical response rates following this therapy in these patients. III. Determine the toxic effects of thalidomide in these patients. IV. Determine the effect of thalidomide on tumor angiogenesis in these patients.
OUTLINE:
Patients receive 4-20 capsules of oral thalidomide once daily. Dose is escalated in individual patients on a weekly basis for the first 5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity, or for 12 months past complete response.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Texas
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Houston, Texas, Forenede Stater, 77030
- University of Texas - MD Anderson Cancer Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
- Histologically proven squamous cell carcinoma of the head and neck
- Recurrent disease OR metastatic disease at initial diagnosis or at recurrence
- Initial therapy of surgery and/or radiotherapy, induction chemotherapy, or concurrent chemotherapy and radiotherapy allowed
- No more than one prior regimen of chemotherapy or biologic therapy for metastatic disease
- Recurrence after adjuvant or induction chemotherapy may have received one additional course of chemotherapy or biologic therapy
PATIENT CHARACTERISTICS:
- Age: 18 and over
- Performance status: Zubrod 0-2
- Life expectancy: At least 3 months
- WBC at least 3000/mm3
- Platelet count at least 100,000/mm3
- Hematocrit at least 30%
- Bilirubin no greater than 1.5 times normal
- SGOT/SGPT no greater than 1.5 times normal
- Creatinine no greater than 1.5 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile women must use 2 methods of effective contraception, 1 barrier and 1 hormonal, beginning at least 4 weeks before study and continuing during and for 1 month after study
- Men must use effective barrier contraception during and for 1 month after study
- No grade 2 or greater peripheral neuropathy
- No serious infection or other concurrent illness requiring immediate therapy
- Must be able to take oral medications
- No medical or social factors that would interfere with compliance
PRIOR CONCURRENT THERAPY:
- Any number of courses of one regimen of chemotherapy allowed
- No concurrent cytotoxic chemotherapy
- No concurrent radiotherapy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm I
Patients receive 4-20 capsules of oral thalidomide once daily.
Dose is escalated in individual patients on a weekly basis for the first 5 weeks.
Treatment continues in the absence of disease progression or unacceptable toxicity, or for 12 months past complete response.
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Roy S. Herbst, MD, PhD, M.D. Anderson Cancer Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- tilbagevendende metastatisk planehalskræft med okkult primær
- metastatisk pladecellekræft med okkult primært pladecellekræft
- stadium IV planocellulært karcinom i læben og mundhulen
- tilbagevendende pladecellekarcinom i læben og mundhulen
- stadium IV planocellulært karcinom i oropharynx
- tilbagevendende pladecellekarcinom i oropharynx
- stadium IV planocellulært karcinom i nasopharynx
- tilbagevendende pladecellekarcinom i nasopharynx
- stadium IV planocellulært karcinom i hypopharynx
- tilbagevendende pladecellekarcinom i hypopharynx
- stadium IV planocellulært karcinom i strubehovedet
- tilbagevendende pladecellekarcinom i strubehovedet
- stadium IV planocellulært karcinom i paranasale sinus og næsehulen
- tilbagevendende pladecellekarcinom i paranasale sinus og næsehulen
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Neoplasmer efter sted
- Neoplasmer i hoved og hals
- Lægemidlers fysiologiske virkninger
- Anti-infektionsmidler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Antibakterielle midler
- Leprostatiske midler
- Thalidomid
Andre undersøgelses-id-numre
- NCI-2012-02299
- MDA-ID-98270
- NCI-T98-0074
- CDR0000067011 (Registry Identifier: PDQ (Physician Data Query))
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