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Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer

30. januar 2013 opdateret af: Roswell Park Cancer Institute

A Phase I Study Of Low-Dose Subcutaneous Interleukin 2 (IL-2) And Stem Cell Factor (r-metHuSCF) For Patients With AIDS And AIDS-Associated Malignancy

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Stem cell factor may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of cancer therapy.

PURPOSE: Phase I trial to study the effectiveness of combining interleukin-2 with stem cell factor in treating patients who have AIDS or AIDS-related cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

OBJECTIVES:

  • Determine the safety and toxicity of low-dose interleukin-2 and stem cell factor in patients with AIDS or AIDS-related malignancies.
  • Determine the immune status of patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of stem cell factor.

Patients receive interleukin-2 (IL-2) subcutaneously (SC) six days a week and stem cell factor SC three times a week for 8 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of stem cell factor until the maximum tolerated dose (MTD) 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 cohort of 3 patients receives treatment at the MTD.

Patients are followed every 2 weeks for 1 month.

PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

    • New York
      • Buffalo, New York, Forenede Stater, 14263-0001
        • Roswell Park Cancer Institute
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • Arthur G. James Cancer Hospital - Ohio State University

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:

  • Diagnosis of HIV-1 by ELISA, Western blot, polymerase chain reaction, or other documentation
  • Must have had 1 of the following AIDS-defining illnesses:

    • Opportunistic infection
    • Opportunistic malignancy (excluding CNS involvement)
    • CD4 T-cell count less than 200/mm^3 (but currently greater than 20/mm^3)
  • Receiving antiretroviral therapy
  • No concurrent Kaposi's sarcoma

    • Prior Kaposi's sarcoma in complete response allowed

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 80-100%

Life expectancy

  • Not specified

Hematopoietic

  • Absolute granulocyte count greater than 1,000/mm^3*
  • Hemoglobin at least 10 g/dL*
  • Platelet count greater than 50,000/mm^3* NOTE: *Transfusions and growth factors allowed in order to increase or maintain counts

Hepatic

  • No major hepatic dysfunction evidenced by encephalopathy, ascites, or varices
  • Bilirubin no greater than 2 mg/dL
  • INR no greater than 1.5

Renal

  • Not specified

Cardiovascular

  • No prior angioedema
  • No uncontrolled hypertension (i.e., diastolic blood pressure greater than 115 mmHg)
  • No unstable angina
  • No New York Heart Association class III or IV heart disease
  • No congestive heart failure
  • No coronary angioplasty within the past 6 months
  • No myocardial infarction within the past 6 months
  • No uncontrolled atrial or ventricular cardiac arrhythmia

Pulmonary

  • No history of seasonal or recurrent asthma within the past 10 years
  • No concurrent asthmatic symptoms (e.g., wheezing) related to a current respiratory tract infection

Immunologic

  • No prior positive allergy test (skin or radioallergosorbent test) for insect venoms
  • No known allergy to E. coli-derived products
  • No prior anaphylactic events manifested by disseminated urticaria, laryngeal edema, and/or bronchospasm
  • Drug allergies manifested solely by rash and/or urticaria allowed
  • No recurrent urticaria (isolated episode of urticaria allowed)
  • No other active uncontrolled infection (including one with current symptoms of bronchoconstriction)
  • No fever of 38.2° C or higher

    • Fevers due to B symptoms allowed

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior or concurrent CNS malignancy
  • No poorly controlled diabetes
  • No other significant nonmalignant disease
  • No other malignancy except those in stable partial response or stable complete response (no evidence of progressive disease for at least 8 weeks after therapy for the malignancy)

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Hematopoietic in Patient Characteristics
  • No prior stem cell factor
  • No concurrent interleukin-11 for thrombocytopenia

Chemotherapy

  • No concurrent chemotherapy for malignancy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No concurrent enrollment on any other protocol utilizing an investigational drug
  • No concurrent beta adrenergic blocking 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.

Samarbejdspartnere

Efterforskere

  • Studiestol: Zale P. Bernstein, MD, Roswell Park Cancer Institute

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. august 2002

Primær færdiggørelse (Faktiske)

1. november 2003

Datoer for studieregistrering

Først indsendt

7. april 2003

Først indsendt, der opfyldte QC-kriterier

8. april 2003

Først opslået (Skøn)

9. april 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. januar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. januar 2013

Sidst verificeret

1. januar 2013

Mere information

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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