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Status:

COMPLETED

Cyclophosphamide and Fludarabine Followed by Vaccine Therapy, Gene-Modified White Blood Cell Infusions, and Aldesleukin in Treating Patients With Metastatic Melanoma

Lead Sponsor:

National Institutes of Health Clinical Center (CC)

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Melanoma (Skin)

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

RATIONALE: Inserting a laboratory-treated gene into a person's white blood cells may make the body build an immune response to kill tumor cells. Giving cyclophosphamide and fludarabine before a white ...

Detailed Description

OBJECTIVES: Primary * Determine the safety of peripheral blood lymphocytes (PBLs) retrovirally transduced with an anti-MART-1 T-cell receptor (TCR) gene followed by high-dose aldesleukin (IL-2) and ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of metastatic melanoma
  • HLA-A\*0201-positive disease
  • Measurable disease
  • Refractory to standard therapy, including high-dose aldesleukin therapy
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0-1
  • Life expectancy
  • More than 3 months
  • Hematopoietic
  • Absolute neutrophil count \> 1,000/mm\^3
  • Platelet count \> 100,000/mm\^3
  • Hemoglobin \> 8.0 g/dL
  • Lymphocyte count \> 500/mm\^3
  • WBC \> 3,000/mm\^3
  • No coagulation disorder
  • Hepatic
  • ALT and AST \< 3 times upper limit of normal
  • Bilirubin ≤ 2.0 mg/dL (\< 3.0 mg/dL for patients with Gilbert's disease)
  • Hepatitis B antigen negative
  • Hepatitis C antibody negative (unless antigen negative)
  • Renal
  • Creatinine ≤ 1.6 mg/dL
  • Cardiovascular
  • No myocardial infarction
  • No cardiac arrhythmias
  • No cardiac ischemia
  • LVEF ≥ 45% by stress cardiac test\* (for patients ≥ 50 years of age OR those with a history of EKG abnormalities)
  • No other major cardiovascular illness by stress thallium or comparable test NOTE: \*Stress thallium, stress MUGA, dobutamine echocardiogram, or other stress test
  • Pulmonary
  • No major respiratory illness
  • No obstructive or restrictive pulmonary disease
  • FEV\_1 ≥ 60% of predicted on pulmonary function test\*
  • DLCO ≥ 60% predicted (for total-body irradiation cohort) NOTE: \*For patients with a prolonged history of cigarette smoking or symptoms of respiratory dysfunction
  • Immunologic
  • HIV negative
  • No major immune system illness
  • No active systemic infection or opportunistic infection
  • No primary immunodeficiency (e.g., autoimmune colitis or Crohn's disease)
  • No secondary immunodeficiency (e.g., due to chemotherapy or radiotherapy)
  • No history of severe immediate hypersensitivity reaction to study drugs
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 4 months after completion of study treatment
  • Must sign a durable power of attorney
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • See Disease Characteristics
  • Recovered from prior immunotherapy
  • Prior immunization to melanoma antigens allowed
  • Progressive disease during prior immunization allowed
  • Prior cellular therapy, including vector transduction with or without myeloablation, allowed
  • More than 6 weeks since prior anticytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) monoclonal antibody (MDX-010) therapy
  • No prior anti-CTLA-4 antibody unless a post anti-CTLA-4 antibody treatment colonoscopy was normal by biopsy
  • Chemotherapy
  • Recovered from prior chemotherapy
  • Endocrine therapy
  • No concurrent systemic steroids
  • Radiotherapy
  • Recovered from prior radiotherapy
  • No prior significant mediastinal or lung radiation (for total-body irradiation cohort)
  • Surgery
  • Not specified
  • Other
  • More than 4 weeks since prior systemic therapy and recovered

Exclusion

    Key Trial Info

    Start Date :

    July 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    October 1 2010

    Estimated Enrollment :

    136 Patients enrolled

    Trial Details

    Trial ID

    NCT00091104

    Start Date

    July 1 2004

    End Date

    October 1 2010

    Last Update

    March 15 2012

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

    Bethesda, Maryland, United States, 20892-1182

    2

    NCI - Surgery Branch

    Bethesda, Maryland, United States, 20892-1201