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High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2

18. december 2013 opdateret af: Blumenthal Cancer Center at Carolinas Medical Center

Treatment of Patients With Metastatic Renal Cell Carcinoma Who Have Failed Low Dose Intensity Interleukin-2 With High-Dose Intravenous Recombinant Interleukin-2

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill renal cell carcinoma (kidney cancer) cells.

PURPOSE: This phase II trial is studying how well high-dose intravenous interleukin-2 works in treating patients with metastatic renal cell carcinoma that has not responded to previous low-dose intravenous or subcutaneous interleukin-2.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

  • Determine the response rate (complete, partial, and minor) in patients with metastatic renal cell carcinoma who failed prior low-dose intravenous or subcutaneous interleukin-2 (IL-2) when treated with high-dose intravenous IL-2.
  • Determine the overall survival, disease-free survival, and time to progression in patients treated with this drug.
  • Determine the toxicity of this drug in these patients.

OUTLINE: This is a pilot study.

Patients receive high-dose interleukin-2 IV every 8 hours for 15 doses followed 7-10 days later by another 15 doses (course 1).

Patients are assesed for response 2 months after initiation of treatment. Patients with responding or stable disease receive a second course of therapy. Patients with an ongoing response receive subsequent courses of treatment in the absence of unacceptable toxicity.

Patients are followed every 6 months for survival.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Undersøgelsestype

Interventionel

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed renal cell carcinoma

    • Metastatic disease
    • No pure papillary or sarcomatoid variants
  • Measurable disease

  • Failed prior subcutaneous OR intravenous (dose ≤ 50,000 IU/kg/day) interleukin-2

    • Documented disease progression
  • No estimated hepatic replacement by tumor > 25% by CT scan or MRI
  • No tumor involving the CNS or a major nerve

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 80-100%

Life expectancy

  • More than 3 months

Hematopoietic

  • Platelet count ≥ 80,000/mm^3
  • No sites of ongoing bleeding

Hepatic

  • See Disease Characteristics
  • Bilirubin ≤ 1.4 mg/dL
  • AST and ALT ≤ 3 times normal
  • PT or PTT INR ≤ 1.2
  • Hepatitis B surface antigen negative
  • Hepatitis C virus negative
  • No coagulation disorders

Renal

  • Creatinine ≤ 1.6 mg/dL

Cardiovascular

  • No ongoing ischemia*
  • No cardiac dysfunction*
  • No abnormal ejection fraction* NOTE: *A cardiac stress test is indicated for all patients ≥ 50 years of age and for any patient with possible cardiac disease as suggested by history, physical exam, or electrocardiogram

Pulmonary

  • FEV_1 ≤ 65% of predicted*
  • Vital capacity ≤ 65% of predicted* NOTE: *Pulmonary function tests are to be performed on any patient with a significant smoking history or suspected pulmonary disease either by history, physical exam, or radiograph

Other

  • HIV negative
  • No AIDS
  • No systemic infections
  • No other malignancy except carcinoma in situ
  • No psychiatric illness that would preclude study participation or compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • Not specified

Endocrine therapy

  • No concurrent steroids

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • More than 28 days since other prior treatment for renal cell cancer
  • No concurrent immunosuppressive agents

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Blumenthal Cancer Center at Carolinas Medical Center

Efterforskere

  • Studiestol: Richard L. White, MD, Blumenthal Cancer Center at Carolinas Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 1998

Datoer for studieregistrering

Først indsendt

7. april 2004

Først indsendt, der opfyldte QC-kriterier

7. april 2004

Først opslået (Skøn)

8. april 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. december 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. december 2013

Sidst verificeret

1. juni 2005

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000357581
  • CMC-10-01-01AH

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner