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CP-751871 In Treating Women With Early-Stage Breast Cancer That Can Be Removed By Surgery

10. mars 2015 oppdatert av: Pfizer

A Phase 1 Pharmacodynamic Study Of CP-751,871 As Neoadjuvant Treatment For Early Breast Cancer

RATIONALE: Monoclonal antibodies, such as CP-751871, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

PURPOSE: This phase I trial is studying the side effects and best way to give CP-751871 in treating patients with early-stage breast cancer that can be removed by surgery.

Studieoversikt

Detaljert beskrivelse

Primary

  • To evaluate the change in total tumor choline levels in women with operable early breast cancer in response to neoadjuvant CP-751871 treatment.

Secondary

  • To assess changes in tumor glucose levels after CP-751871 treatment using magnetic resonance spectroscopy in these patients.
  • To assess the safety, tolerability, and immunogenicity of CP-751871 in these patients.
  • To assess the effect of CP-751871 on Insulin-like Growth Factor 1 receptor (IGF-1R) signaling markers in tumor tissues in these patients.
  • To assess the clinical efficacy of CP-751871 in these patients (MRI and pathological responses).

OUTLINE: Patients receive CP-751871 IV over 5 hours on days 1 and 22 and undergo magnetic resonance spectroscopy on days 8 and 29. Patients may also undergo surgery between days 29-43 to obtain a tumor sample for analysis of markers related to the IGR-1R pathway.

After completion of study treatment, patients will be followed for 5 months.

Studietype

Intervensjonell

Fase

  • Fase 1

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed early operable adenocarcinoma of the breast
  • No evidence of invasive lobular breast disease
  • Measurable disease, defined as at least 1 lesion ≥ 2 cm by MRI
  • Measurable levels of total choline according to institutional criteria by magnetic resonance spectroscopy
  • Must have available or scheduled core breast biopsy procedure
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • ECOG performance status 0-1
  • Platelet count ≥ 100,000/mm^³
  • Neutrophil count ≥ 1,500/mm³
  • Creatinine < 1.5 times upper limit of normal (ULN)
  • Bilirubin < 1.5 times ULN
  • ALT and AST < 2.5 times ULN
  • Fertile patients must use adequate barrier method contraception during and for at least 150 days after completion of study treatment
  • Ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
  • No known hypersensitivity to monoclonal antibodies
  • No prior or active malignancies other than curatively treated in situ carcinoma of the cervix, uterus, or basal cell or squamous cell carcinoma of the skin
  • No serious uncontrolled medical disorder or active infection that would impair the ability to receive study treatment
  • No significant active cardiac disease including any of the following:

    • Uncontrolled high blood pressure (i.e., systolic blood pressure [BP] > 160 mm Hg and diastolic BP > 95 mm Hg)
    • Unstable angina
    • Deep venous thrombosis
    • Pulmonary embolism
    • Cerebrovascular attack
    • Valvular disease
    • Congestive heart failure
    • Myocardial infarction with the past 6 months
    • Serious cardiac arrhythmias
  • No dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with study requirements

PRIOR CONCURRENT THERAPY:

  • More than 4 weeks since prior surgery and recovered
  • More than 2 weeks since high-dose corticosteroid therapy (i.e., ≥ 100 mg prednisone per day or > 40 mg dexamethasone per day)
  • No prior anti-IGF-1R based investigational therapy
  • No prior systemic therapy for primary disease
  • No concurrent chronic systemic high-dose immunosuppressive steroid therapy

    • Low-dose steroids for nausea and vomiting control allowed
    • Topical corticosteroid applications, inhaled sprays, eye drops or local injections (e.g., intraocular) allowed
  • No concurrent other anticancer drugs or therapy

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

Resultatmål
Tumor total choline (tCho) changes determined by magnetic resonance spectroscopy

Sekundære resultatmål

Resultatmål
Patologisk respons
Safety, tolerability and human anti-human antibodies (HAHA) response
Tissue markers
Measure of tumor glucose levels
Tumor size by MRI

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Douglas Yee, MD, Masonic Cancer Center, University of Minnesota

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Datoer for studieregistrering

Først innsendt

12. mars 2008

Først innsendt som oppfylte QC-kriteriene

12. mars 2008

Først lagt ut (Anslag)

13. mars 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

11. mars 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. mars 2015

Sist bekreftet

1. mars 2015

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • A4021012
  • P30CA077598 (U.S. NIH-stipend/kontrakt)
  • NCI-CDR0000589252

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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