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Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Study NCT00039091   Information provided by National Cancer Institute (NCI)
First Received: June 6, 2002   Last Updated: February 6, 2009   History of Changes

June 6, 2002
February 6, 2009
March 2002
July 2003   (final data collection date for primary outcome measure)
Biologic activity by radiology and pathology every 2 months [ Designated as safety issue: No ]
Biologic activity by radiology and pathology every 2 months
Complete list of historical versions of study NCT00039091 on ClinicalTrials.gov Archive Site
 
 
 
Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer
Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 (Anti-CTLA-4) Humanized Monoclonal Antibody (MDX-CTLA-4 NSC # 732442 [Previously # 720801]) in Patients Previously Vaccinated With GM CSF-Based Autologous Tumor Vaccines (CTEP Protocol Number P-5708) and Patients With Acute Myelogenous Leukemia/Myelodysplasia, and Non-Small Cell Lung Cancer Who Have Not Received Prior Vaccine

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: This phase I trial is studying the side effects of monoclonal antibody therapy in treating patients with ovarian epithelial cancer, melanoma, acute myeloid leukemia, myelodysplastic syndrome, or non-small cell lung cancer.

OBJECTIVES:

  • Determine the safety of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody in patients with ovarian epithelial cancer, melanoma, acute myeloid leukemia, myelodysplastic syndromes, or non-small cell lung cancer not previously treated with sargramostim (GM-CSF)-based autologous tumor vaccines.
  • Determine, preliminarily, the biologic activity and efficacy of this drug in these patients.

OUTLINE: Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes on day 1. Courses repeat every 2 months in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly until disease progression.

PROJECTED ACCRUAL: A total of 48 patients (12 per disease type; 36 previously treated with a sargramostim (GM-CSF)-expressing autologous tumor cell vaccine and 12 not previously treated with this vaccine) will be accrued for this study.

Phase I
Interventional
Treatment, Open Label
  • Leukemia
  • Lung Cancer
  • Melanoma (Skin)
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • Ovarian Cancer
Biological: ipilimumab
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
48
 
July 2003   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:

    • Ovarian epithelial cancer

      • Persistent or recurrent disease after primary surgery and chemotherapy
      • Received prior sargramostim (GM-CSF)-expressing autologous tumor cell vaccine
    • Melanoma

      • Stage IV disease
      • Received prior sargramostim (GM-CSF)-expressing autologous tumor cell vaccine
    • Acute myeloid leukemia (AML) meeting 1 of the following criteria:

      • Second relapse
      • First relapse with no option for bone marrow transplantation
      • Ineligible for immunosuppressive chemotherapy due to age or comorbid disease
    • Myelodysplastic syndromes (MDS)
    • Non-small cell lung cancer

      • Incurable by standard surgery, chemotherapy, and/or radiotherapy
  • No standard curative treatment exists
  • No immediate palliative therapy required
  • Measurable disease
  • No CNS metastases unless previously treated and stable for at least 3 months

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • WBC greater than 1,000/mm^3*
  • Platelet count greater than 75,000/mm^3* NOTE: * Except for patients with AML/MDS

Hepatic:

  • Bilirubin less than 2 times upper limit of normal (ULN)
  • AST and ALT less than 2 times ULN

Renal:

  • Creatinine less than 2 mg/dL

Immunologic

  • No active infection
  • No autoimmune disease requiring immunosuppressive treatment
  • No active autoimmune disease threatening vital organ function
  • No significant history of autoimmune disease that could be reactivated, including any of the following:

    • CNS (e.g., multiple sclerosis)
    • Eye (e.g., uveitis)
    • Intestine (e.g., irritable bowel disease)
    • Liver (e.g., hepatitis)
    • Kidney
    • Connective tissue disease (e.g., systemic lupus erythematosus, scleroderma, or polymyositis)
    • Heart (e.g., myocarditis)
  • Possible autoimmune diseases that are managed with replacement therapy are allowed (e.g., diabetes mellitus or hypothyroid)

Other:

  • No underlying medical condition that would preclude study participation
  • No concurrent medical condition requiring systemic steroids
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • At least 4 weeks since prior immunotherapy
  • No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy

Endocrine therapy:

  • At least 4 weeks since prior hormonal therapy
  • At least 4 weeks since prior systemic corticosteroids
  • Concurrent inhaled or topical steroids allowed

Radiotherapy:

  • At least 4 weeks since prior radiotherapy

Surgery:

  • See Disease Characteristics
  • At least 4 weeks since prior major surgical procedures

Other:

  • At least 4 weeks since other prior therapy
  • Recovered from prior therapy
  • No other concurrent investigational drugs
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00039091
 
CDR0000069349, DFCI-NCI-5708, NCI-5708
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: F. Stephen Hodi, MD Dana-Farber Cancer Institute
National Cancer Institute (NCI)
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP