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Clinical Trial Summary

This phase I trial is studying how well ipilimumab works after allogeneic stem cell transplant in treating patients with persistent or progressive cancer. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the dose of MDX-010 (ipilimumab) that can safely be administered to patients with persistent or progressive malignancy following allo-HCT.

II. To determine the pharmacokinetics of different doses of MDX-010 administered as a single dose to patients with persistent or progressive malignancy following allo-HCT.

III. By assessment of aims 1 and 2, to determine the best dosing regimen for further study of CTLA-4 blockade in conjunction with escalating dose donor-leukocyte infusions (DLI) in patients with evidence of residual or progressive malignancy following allo-HCT.

IV. To assess if there is preliminary evidence of efficacy following the administration of MDX-010 in this population.

OUTLINE:

Patients receive ipilimumab intravenously (IV) over 90 minutes.

Cohorts of 3-6 patients receive escalating doses of ipilimumab until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients with persistent or progressive disease at 60 days after ipilimumab administration and no evidence of graft-versus-host disease receive donor lymphocyte infusions every 60 days for a total of 3 infusions.

Patients are followed at 4, 5, 6, 9, and 12 months and then annually thereafter. ;


Study Design

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


Related Conditions & MeSH terms

  • 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
  • Breast Neoplasms
  • Burkitt Lymphoma
  • Carcinoma
  • Childhood Myelodysplastic Syndromes
  • Choriocarcinoma
  • Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Dermoid Cyst
  • Disseminated Neuroblastoma
  • Germinoma
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Large-Cell, Immunoblastic
  • Lymphoma, Mantle-Cell
  • Lymphoma, Non-Hodgkin
  • Malignant Neoplasm
  • Multiple Myeloma
  • Myelodysplastic Syndromes
  • Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Neoplasms, Glandular and Epithelial
  • Neoplasms, Plasma Cell
  • Neuroblastoma
  • Ovarian Choriocarcinoma
  • Ovarian Embryonal Carcinoma
  • Ovarian Immature Teratoma
  • Ovarian Mature Teratoma
  • Ovarian Mixed Germ Cell Tumor
  • Ovarian Monodermal and Highly Specialized Teratoma
  • Ovarian Neoplasms
  • Ovarian Polyembryoma
  • Ovarian Yolk Sac Tumor
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Preleukemia
  • Previously Treated Myelodysplastic Syndromes
  • Recurrent Adult Acute Lymphoblastic Leukemia
  • Recurrent Adult Acute Myeloid Leukemia
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Diffuse Mixed Cell Lymphoma
  • Recurrent Adult Hodgkin Lymphoma
  • Recurrent Adult Immunoblastic Large Cell Lymphoma
  • Recurrent Adult Lymphoblastic Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Malignant Testicular Germ Cell Tumor
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Neuroblastoma
  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Ovarian Germ Cell Tumor
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Multiple Myeloma
  • Relapsing Chronic Myelogenous Leukemia
  • Seminoma
  • Stage I Multiple Myeloma
  • Stage II Multiple Myeloma
  • Stage II Ovarian Epithelial Cancer
  • Stage III Malignant Testicular Germ Cell Tumor
  • Stage III Multiple Myeloma
  • Stage III Ovarian Epithelial Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Syndrome
  • Teratoma
  • Testicular Choriocarcinoma
  • Testicular Choriocarcinoma and Embryonal Carcinoma
  • Testicular Choriocarcinoma and Seminoma
  • Testicular Choriocarcinoma and Teratoma
  • Testicular Choriocarcinoma and Yolk Sac Tumor
  • Testicular Embryonal Carcinoma
  • Testicular Embryonal Carcinoma and Seminoma
  • Testicular Embryonal Carcinoma and Teratoma
  • Testicular Embryonal Carcinoma and Teratoma With Seminoma
  • Testicular Embryonal Carcinoma and Yolk Sac Tumor
  • Testicular Embryonal Carcinoma and Yolk Sac Tumor With Seminoma
  • Testicular Neoplasms
  • Testicular Teratoma
  • Testicular Yolk Sac Tumor
  • Testicular Yolk Sac Tumor and Teratoma
  • Testicular Yolk Sac Tumor and Teratoma With Seminoma

NCT number NCT00060372
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 1
Start date April 2003

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