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Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer

19 juni 2013 uppdaterad av: National Cancer Institute (NCI)

A Phase I/II Trial of Vaccination With Mutant Ras Peptide-Pulsed Dendritic Cells in the Treatment of HLA A2.1 Positive Patients With Colorectal Cancer

RATIONALE: Vaccines may make the body build an immune response that will kill cancer cells. Combining vaccine therapy with interleukin-2 may kill more cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have locally advanced or metastatic colorectal cancer.

Studieöversikt

Detaljerad beskrivning

OBJECTIVES:

  • Determine the frequency of immunologic response in patients with locally advanced or metastatic colorectal cancer treated with ras peptide-pulsed dendritic cell vaccine with or without interleukin-2.
  • Determine the tumor response and survival time in patients with metastatic colorectal cancer treated with vaccine plus interleukin-2.
  • Determine the time to progression in patients with locally advanced colorectal cancer treated with adjuvant vaccine.

OUTLINE: Patients are assigned to 1 of 2 treatment groups according to extent of disease. Patients with prior locally advanced disease are assigned to treatment group A, while those with metastatic disease are assigned to treatment group B.

  • Group A: Patients are vaccinated against influenza on day -6. Patients undergo collection of peripheral blood mononuclear cells (PBMC) on day -4. The PBMC are cultured with sargramostim (GM-CSF) and interleukin-4 for 5 days and CD40 ligand for 24 hours and then pulsed for 2 hours with the appropriate peptide to form a vaccine. Patients receive ras peptide-pulsed dendritic cell vaccine IV over 5 minutes on days 1, 15, 29, 43, and 57.
  • Group B: Patients undergo collection of PBMC and receive vaccination as in group A. Patients also receive interleukin-2 subcutaneously on days 2-6 and 9-13.

Treatment in both groups repeats every 2 weeks for up to 5 vaccinations in the absence of disease progression or unacceptable toxicity.

Patients are followed on days 75, 90, 120, and 365.

PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 3 years.

Studietyp

Interventionell

Fas

  • Fas 2
  • Fas 1

Kontakter och platser

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

Studieorter

    • Maryland
      • Bethesda, Maryland, Förenta staterna, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
    • Tennessee
      • Nashville, Tennessee, Förenta staterna, 37232-6838
        • Vanderbilt-Ingram Cancer 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

DISEASE CHARACTERISTICS:

  • Histologically confirmed locally advanced or metastatic colorectal cancer
  • Metastatic disease must be radiologically proven
  • HLA-A2-1 positive
  • Locally advanced disease must have had prior resection or incomplete resection with poor prognosis
  • Locally advanced disease includes:

    • Stage III or IV colon cancer (T4 or any T, N2-3, M0)
    • Stage III or IV rectal cancer (T4 or T3, N1-3)
    • Resectable or unresectable T4 disease after radiotherapy, chemotherapy, and/or surgery
    • Absence of measurable disease but more than a 50% chance of recurrence
  • Completely resected or locally advanced disease may have had conventional therapy completed within 1-12 months (surgery alone, with or without adjuvant chemotherapy and/or radiotherapy) prior to study entry
  • Metastatic disease patients must have bidimensionally measurable disease

    • Bone lesions with well-demarcated borders allowed
    • Lesions seen only on bone scan, pleural effusions, ascites, and changes in carcinoembryonic antigen are not considered measurable disease

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Lymphocyte count at least 470/mm^3
  • Granulocyte count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL*
  • SGOT no greater than 4 times upper limit of normal (ULN) (2.5 times ULN for adjuvant patients)*
  • Albumin at least 3 g/dL
  • No active viral hepatitis
  • No evidence of chronic infection due to hepatitis C
  • Hepatitis B surface antigen negative NOTE: *Unless due to metastatic disease

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • No history of cardiac failure, significant arrhythmias, or coronary artery disease (metastatic disease patients only)

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No prior malignancy with a 50% chance of recurrence within 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
  • No medical or psychiatric condition that would preclude compliance
  • No serious medical condition that would preclude apheresis
  • No serious infection
  • No uncontrolled thyroid disease (metastatic disease patients only)
  • Patients with an allergy to eggs are allowed but are not vaccinated against influenza during study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunologic therapy directed at the cellular immune system

Chemotherapy:

  • See Disease Characteristics
  • Prior chemotherapy for metastatic disease allowed
  • At least 4 weeks since prior chemotherapy
  • No concurrent chemotherapy or anticipated need for chemotherapy for 2 months after vaccinations

Endocrine therapy:

  • At least 4 weeks since prior supraphysiologic steroid therapy

Radiotherapy:

  • See Disease Characteristics
  • Prior radiotherapy for metastatic disease allowed
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • Prior surgery for metastatic disease allowed

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Response rate every 3 months for up to a year after completion of study treatment

Samarbetspartners och utredare

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

Utredare

  • Studiestol: John E. Janik, MD, NCI - Metabolism Branch;MET

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 mars 1999

Avslutad studie (Faktisk)

1 november 2005

Studieregistreringsdatum

Först inskickad

11 juli 2001

Först inskickad som uppfyllde QC-kriterierna

26 januari 2003

Första postat (Uppskatta)

27 januari 2003

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

20 juni 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 juni 2013

Senast verifierad

1 november 2005

Mer information

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 .

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