Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Vaccine Therapy in Treating Patients With Metastatic Solid Tumors

23 januari 2013 uppdaterad av: National Cancer Institute (NCI)

Intra-Lesional rF-B7.1 Versus rF-Tricom Vaccine In The Treatment Of Metastatic Cancer

Randomized phase I trial to compare the effectiveness of two different vaccines given directly into the tumor in treating patients who have metastatic solid tumors. Vaccines may make the body build an immune response to kill tumor cells. Infusing the vaccine directly into a tumor may cause a stronger immune response and kill more tumor cells. It is not yet known which vaccine may be more effective in treating metastatic solid tumors

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

PRIMARY OBJECTIVES:

I. To determine and compare the feasibility and clinical toxicity of administering rF-B7.1 and rF-TRICOM vaccines to patients with accessible cutaneous, subcutaneous, or lymph node metastatic tumors.

II. To determine and compare the feasibility and clinical toxicity of administering rF-B7.1 and rF-TRICOM vaccines to patients with accessible visceral metastatic tumors.

III. To determine the optimal dose of rF-B7.1 and rF-TRICOM vaccine delivered by intra-tumoral injection.

IV. To compare the clinical responses and safety profile of patients with cutaneous tumors and visceral tumors who receive rF-B7.1 vaccine to similar patients receiving rF-TRICOM vaccine.

SECONDARY OBJECTIVES:

I. To establish evidence of host anti-tumor immune reactivity following intra-lesional vaccine administration and compare any differences between rF-B7.1 and rF-TRICOM in patients with cutaneous tumors and visceral tumors.

II. To evaluate the quality of life during vaccine administration.

OUTLINE: This is a randomized study with dose-escalation component. Patients are stratified according to tumor location (cutaneous, subcutaneous, or lymph node metastases vs visceral metastases). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive rF-B7.1 vaccine intratumorally on day 1.

ARM II: Patients receive fowlpox-TRICOM vaccine intratumorally on day 1.

Treatment in both arms repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional courses.

Three patients from the cutaneous disease (CD) stratum are treated at low-dose in each treatment arm. If no more than 1 of 6 patients experience dose-limiting toxicity (DLT), then 6 additional CD patients are randomized to high-dose treatment. If no more than 1 of these 6 patients experience DLT, then 12 patients from the visceral disease (VD) stratum are randomized to low-dose treatment. If no more than 2 of 12 VD patients experience DLT, then the next cohort of 12 VD patients is randomized to high-dose treatment. If 3 of the original 12 VD patients experience DLT, then 6 additional VD patients receive low-dose treatment. If no more than 3 of 18 patients experience DLT, then 12 VD patients receive high-dose treatment.

Quality of life is assessed at baseline, monthly during therapy, and then at the end of therapy.

Patients are followed every 3 months.

Studietyp

Interventionell

Inskrivning (Faktisk)

42

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • New York
      • New York, New York, Förenta staterna, 10029
        • Mount Sinai Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Histologically confirmed metastatic unresectable solid tumors

    • Cutaneous, subcutaneous, lymph node, or visceral tumors that are accessible to imaging and injections
    • No standard therapy available

  • At least 1 unidimensionally measurable lesion

    • At least 20 mm for visceral lesions
    • At least 10 mm for cutaneous, subcutaneous, and nodal lesions

  • No untreated or edematous metastatic brain lesions

    • At least 6 weeks since prior surgery and/or radiotherapy for brain metastases and no evidence of disease or edema on CT scan or MRI
  • No ascites or pleural effusions
  • No leptomeningeal disease
  • Performance status - ECOG 0-1
  • More than 3 months
  • Absolute granulocyte count at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • No bleeding diathesis
  • Bilirubin no greater than 1.5 mg/dL*
  • SGOT/SGPT no greater than 2 times upper limit of normal (ULN)*
  • Alkaline phosphatase no greater than 2 times ULN*
  • No elevated PT or PTT
  • No cirrhosis
  • No active hepatitis
  • No hepatic insufficiency
  • Creatinine no greater than 2.0 mg/dL
  • No renal insufficiency
  • No chronic obstructive pulmonary disorder
  • No active autoimmune disorders
  • No active immunologically mediated disease (e.g., severe psoriasis, colitis, idiopathic thrombocytopenic purpura, multiple sclerosis, connective tissue disease, or active rheumatoid arthritis)
  • No significant allergy or hypersensitivity to eggs
  • No active seizure disorder
  • No active or chronic infections
  • No other significant medical disease that would preclude study participation
  • No other malignancy within the past 5 years except stage I cervical cancer or basal cell carcinoma
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • More than 8 weeks since prior immunotherapy and recovered
  • More than 4 weeks since prior chemotherapy and recovered
  • At least 4 weeks since prior systemic corticosteroids
  • No concurrent corticosteroids
  • More than 2 weeks since prior radiotherapy and recovered
  • No evidence of bone marrow toxicity from prior radiotherapy
  • More than 4 weeks since prior surgery and recovered

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Arm I (recombinant fowlpox-B7.1 vaccine)
Patients receive rF-B7.1 vaccine intratumorally on day 1.
Övrig: laboratoriebiomarköranalys
Korrelativa studier
Procedur: livskvalitetsbedömning
Sidostudier
Andra namn:
  • livskvalitetsbedömning
Biologisk: recombinant fowlpox-B7.1 vaccine
Given intratumorally
Andra namn:
  • rF-B7.1
  • rF-B7.1 vaccine
Experimentell: Arm II (recombinant fowlpox-TRICOM vaccine)
Patients receive fowlpox-TRICOM vaccine intratumorally on day 1.
Övrig: laboratoriebiomarköranalys
Korrelativa studier
Procedur: livskvalitetsbedömning
Sidostudier
Andra namn:
  • livskvalitetsbedömning
Biologisk: rekombinant fågelkopps-TRICOM-vaccin
Ges intratumoralt
Andra namn:
  • rF-TRICOM (B7.1.iCAM1-LFA3-Fowkoppor)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentages of the DLTEs
Tidsram: 12 weeks
Will be summarized and compared between arms, doses, and disease groups using Fisher's exact test.
12 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion of patients with any response (CR, PR, or SD)
Tidsram: 12 weeks
First, the proportion with any response (CR, PR or SD) will be compared to those with no response (PD). Secondly, the proportion of any response (CR, PR or SD) compared to no response (PD) will be compared between the two treatment arms.
12 weeks
Immune response
Tidsram: 12 weeks
Number of T-cells after treatment compared to those measured at baseline, and difference calculated as after-treatment minus baseline. First comparison includes all subjects who completed treatment. Mean change in T-Cells (final-baseline) tested against 0 with 2-tailed, 1-sample t-test, with alpha=.05. Second analysis compares mean change in T-Cells between arms. Performed as a 2-tailed, 2 independent samples t-test, with alpha=.05. Third comparison is a sub-set analysis of patients with melanoma.
12 weeks
Change in quality of life, assessed using the FACT-G survey of emotional and functional well being
Tidsram: Baseline to 12 weeks
A mean observed change in the FACT-G score will be tested against 0 (no change) for the group as a whole. Secondly, the change in score will be compared between the two treatment arms. The overall mean change will also be compared to historical controls either from the literature for cancer patients or to the values for non-subject cancer patients receiving other therapies. Comparisons will be by t-test if the sample distribution meets parametric assumptions. If not non-parametric procedures will be used.
Baseline to 12 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Cancer Institute (NCI)

Utredare

  • Huvudutredare: Howard Kaufman, Icahn School of Medicine at Mount Sinai

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2001

Primärt slutförande (Faktisk)

1 april 2010

Studieregistreringsdatum

Först inskickad

14 februari 2002

Först inskickad som uppfyllde QC-kriterierna

26 januari 2003

Första postat (Uppskatta)

27 januari 2003

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

24 januari 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 januari 2013

Senast verifierad

1 januari 2013

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NCI-2012-02455
  • CPMC-IRB-14535
  • CDR0000069189 (Registeridentifierare: PDQ (Physician Data Query))

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera