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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 a Prior Vaccine


Phase 1
19 Years
N/A
Not Enrolling
Both
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Myeloid Leukemia, Recurrent Melanoma, Recurrent Non-small Cell Lung Cancer, Recurrent Ovarian Epithelial Cancer, Stage IV Melanoma, Stage IV Non-small Cell Lung Cancer

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Trial Information

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 a Prior Vaccine


PRIMARY OBJECTIVES:

I. To determine the safety of MDX-CTLA-4 in patients previously and not previously
vaccinated with GM-CSF-based vaccines using lethally irradiated, autologous melanoma,
ovarian cancer, acute myelogenous leukemia/myelodysplasia or lung cancer cells.

II. To identify preliminary evidence of biologic activity and efficacy.

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.


Inclusion Criteria:



- Patients previously vaccinated with GM-CSF-based vaccines using lethally irradiated,
autologous melanoma, ovarian cancer, acute myelogenous leukemia/myelodysplasia, or
non-small cell lung cancer cells; patients with acute myelogenous
leukemia/myelodysplasia or non-small cell lung cancer who have not been vaccinated
with an autologous, GM-CSF based vaccine

- >= 4 weeks since treatment (chemo-, radiation, hormone, immuno-, etc., therapy)

- Patients must have recovered from any acute toxicity associated with prior therapy

- Measurable epithelial ovarian cancer, melanoma, AML/MDS, or non-small cell lung
cancer

- No standard curative treatment options

- Not require immediate palliative therapy

- Patients with epithelial ovarian cancer must have persistent or recurrent disease
following primary surgery and primary chemotherapy

- Patients with melanoma must be stage IV disease

- Patients with AML/MDS, but without MDS, must be: a) in second relapse or b) first
relapse with no option for bone marrow transplant or c) not a candidate for
immunosuppressive chemotherapy due to age or comorbid disease

- Patients with non-small cell lung cancer must be not curable by standard surgery,
chemotherapy, and/or radiation

- Life expectancy >= 12 weeks

- ECOG performance status of 0, 1 or 2

- Written informed consent

- Due to the unknown effects of MDX-CTLA-4 on the fetus or nursing infant, pregnant or
nursing women should not be included; women should be either: post-menopausal for at
least 1 year; surgically incapable of bearing children; or utilizing an intrauterine
device, and/or spermicide and barrier, for contraception; during the study, use of
oral contraception alone is not acceptable; women of childbearing potential must have
a negative serum beta-HCG pregnancy test conducted during screening, and a negative
urinary beta-HCG pregnancy test conducted within 24 hours prior to treatment; due to
the unknown effects of MDX-CTLA-4 on the fetus, men should not father children during
the study

- WBC > 1,000 cells/mm^3 (except for AML/MDS patients)

- Serum creatinine < 2 mg/dL

- Platelets > 75,000 cells/mm^3 (except for AML/MDS patients)

- AST and ALT < 2 x UNL

- Total bilirubin < 2 x UNL

Exclusion Criteria:

- Active infection

- Autoimmune disease requiring immunosuppressive treatment

- Any underlying medical condition which, in the principal investigator's opinion, will
make the administration of study drug hazardous or obscure the interpretation of
adverse events

- Any concurrent medical condition requiring the use of systemic steroids (use of
inhaled or topical steroids is acceptable)

- CNS metastases, unless previously treated and stable for at least three months

- Patients who have received prior treatment with MDX-CTLA-4

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicities of ipilimumab, based on the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0

Outcome Time Frame:

Up to 6 years

Safety Issue:

Yes

Principal Investigator

Frank Hodi

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-03144

NCT ID:

NCT00039091

Start Date:

March 2002

Completion Date:

Related Keywords:

  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
  • Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
  • Previously Treated Myelodysplastic Syndromes
  • Recurrent Adult Acute Myeloid Leukemia
  • Recurrent Melanoma
  • Recurrent Non-Small Cell Lung Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Stage IV Melanoma
  • Stage IV Non-Small Cell Lung Cancer
  • Congenital Abnormalities
  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lung Neoplasms
  • Melanoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115