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Status:

COMPLETED

Denileukin Diftitox Followed by Vaccine Therapy in Treating Patients With Metastatic Cancer

Lead Sponsor:

H. Kim Lyerly

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Breast Cancer

Colorectal Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

RATIONALE: Combinations of biological substances in denileukin diftitox may be able to carry cancer-killing substances directly to the cancer cells. Vaccines made from a gene-modified virus and a pers...

Detailed Description

OBJECTIVES: Primary * Determine the safety and feasibility of two different schedules of denileukin diftitox followed by active immunotherapy comprising autologous dendritic cells infected with reco...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed malignancy
  • Metastatic disease
  • Tumor expresses carcinoembryonic antigen (CEA), as evidenced by any of the following:
  • At least 50% of tumor expresses CEA by immunohistochemistry (IHC) with ≥ a moderate intensity of staining
  • Peripheral blood CEA level \> 5.0 ng/mL
  • Tumor known to be universally CEA-positive (e.g., colon or rectal cancer)
  • Measurable or evaluable disease
  • Received or refused prior therapy with a possible survival or palliative benefit AND meets the following disease-specific criteria:
  • Patients with colorectal cancer must have experienced disease progression during ≥ 1 prior palliative chemotherapy regimen for metastatic disease comprising 1 of the following regimens:
  • Fluorouracil or capecitabine AND oxaliplatin
  • Fluorouracil or capecitabine AND irinotecan
  • Chemotherapy in combination with bevacizumab
  • Patients with breast cancer must have experienced disease progression during ≥ 1 prior palliative chemotherapy regimen for metastatic disease comprising 1 of the following regimens:
  • Anthracycline- or taxane-based chemotherapy
  • Chemotherapy AND trastuzumab (Herceptin®) (required for patients with tumors overexpressing HER2/neu (i.e., 3+ by IHC or positive by fluorescence in situ hybridization \[FISH\])
  • Patients with lung cancer must have experienced disease progression during ≥ 1 prior palliative chemotherapy regimen for metastatic disease comprising 1 of the following regimens:
  • Platinum-based (e.g., cisplatin or carboplatin) chemotherapy (for chemotherapy-naive patients only)
  • Taxane-based (e.g., docetaxel or paclitaxel) chemotherapy OR vinorelbine (for patients who received prior chemotherapy)
  • Patients with pancreatic cancer must have experienced disease progression during prior chemotherapy, including gemcitabine
  • Patients with other malignancies must have experienced disease progression after prior first-line therapy that would confer a survival or palliative benefit, if such a therapy exists
  • Patients who experienced disease progression during prior first-line palliative chemotherapy must be advised regarding second-line therapy before study enrollment
  • Previously resected brain metastases allowed provided there is no evidence of brain metastasis within the past month by MRI or CT scan
  • No requirement for further systemic chemotherapy for ≥ 3 months
  • Hormone receptor status:
  • Not specified
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Sex
  • Male or female
  • Menopausal status
  • Not specified
  • Performance status
  • Karnofsky 70-100%
  • Life expectancy
  • More than 6 months
  • Hematopoietic
  • WBC ≥ 3,000/mm\^3
  • Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa allowed)
  • Platelet count ≥ 100,000/mm\^3
  • Hepatic
  • Bilirubin \< 1.5 mg/dL (≤ 2.0 mg/dL for patients with Gilbert's syndrome)
  • SGOT and SGPT \< 1.5 times upper limit of normal
  • Albumin ≥ 3.0 g/dL
  • No active acute or chronic viral hepatitis
  • Hepatitis B surface antigen negative
  • Hepatitis C negative
  • No other hepatic disease that would preclude study treatment
  • Renal
  • Creatinine \< 1.5 mg/dL
  • No active acute or chronic urinary tract infection
  • Cardiovascular
  • No New York Heart Association class III-IV cardiac disease
  • Immunologic
  • HIV negative
  • No history of autoimmune disease\*, including, but not limited to, the following:
  • Inflammatory bowel disease
  • Systemic lupus erythematosus
  • Ankylosing spondylitis
  • Scleroderma
  • Multiple sclerosis
  • No active cytomegalovirus (CMV) disease
  • Patients with CMV-seropositivity are eligible
  • No other active acute or chronic infection
  • No history of allergies to eggs or any component of the study vaccine, denileukin diftitox, or diphtheria toxin NOTE: \*Patients with a positive anti-nuclear antibody (ANA) ≤ 1:256 with no other evidence of autoimmune disease are eligible
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 4 months after completion of study treatment
  • No acute or chronic skin disorder that would preclude study treatment
  • No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer
  • No psychological or medical impediment that would preclude study compliance
  • No other serious acute or chronic illness that would preclude study treatment
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • See Disease Characteristics
  • Prior vaccine, dendritic cell, or CEA-targeted immunotherapy allowed
  • At least 4 weeks since prior and no other concurrent immunotherapy
  • Concurrent palliative single-agent trastuzumab for breast cancer allowed provided patient has been on therapy for ≥ 3 months before study entry
  • Chemotherapy
  • See Disease Characteristics
  • At least 4 weeks since prior and no concurrent chemotherapy
  • Endocrine therapy
  • At least 4 weeks since prior hormonal therapy
  • At least 6 weeks since prior steroid therapy except steroids used as premedication for chemotherapy or contrast-enhanced studies
  • No concurrent steroids, including corticosteroids administered to manage toxic effects from dendritic cell or denileukin diftitox administration
  • Concurrent palliative endocrine therapy for breast cancer allowed provided patient has been on therapy for ≥ 3 months before study entry
  • Radiotherapy
  • At least 4 weeks since prior and no concurrent radiotherapy
  • Surgery
  • See Disease Characteristics
  • Other
  • Recovered from all prior therapy
  • At least 4 weeks since prior investigational drugs or procedures
  • At least 4 weeks since other prior therapy
  • No other concurrent immunosuppressive therapy (e.g., azathioprine or cyclosporine)

Exclusion

    Key Trial Info

    Start Date :

    September 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 1 2009

    Estimated Enrollment :

    24 Patients enrolled

    Trial Details

    Trial ID

    NCT00128622

    Start Date

    September 1 2005

    End Date

    May 1 2009

    Last Update

    November 12 2012

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, United States, 20007

    2

    Duke Comprehensive Cancer Center

    Durham, North Carolina, United States, 27710