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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.
First Received: June 6, 2002   Last Updated: February 6, 2009   History of Changes
Sponsor: Dana-Farber Cancer Institute
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00039091
  Purpose

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.


Condition Intervention Phase
Leukemia
Lung Cancer
Melanoma (Skin)
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Ovarian Cancer
Biological: ipilimumab
Phase I

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Biologic activity by radiology and pathology every 2 months [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: March 2002
Estimated Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039091

Locations
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Study Chair: F. Stephen Hodi, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069349, DFCI-NCI-5708, NCI-5708
Study First Received: June 6, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00039091     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
recurrent adult acute myeloid leukemia
stage IV melanoma
recurrent melanoma
previously treated myelodysplastic syndromes
recurrent non-small cell lung cancer
stage IV non-small cell lung cancer
atypical chronic myeloid leukemia
myelodysplastic/myeloproliferative disease, unclassifiable
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with t(15;17)(q22;q12)

Additional relevant MeSH terms:
Thoracic Neoplasms
Immunologic Factors
Precancerous Conditions
Gonadal Disorders
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Urogenital Neoplasms
Ovarian Diseases
Leukemia, Myeloid, Acute
Melanoma
Antibodies, Monoclonal
Genital Diseases, Female
Leukemia
Preleukemia
Pathologic Processes
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Syndrome
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
Endocrine Gland Neoplasms
Respiratory Tract Neoplasms
Disease
Ovarian Neoplasms
Neoplasms by Histologic Type
Hematologic Diseases
Myelodysplastic Syndromes
Genital Neoplasms, Female
Myeloproliferative Disorders

ClinicalTrials.gov processed this record on November 09, 2009