Ipilimumab After Allogeneic Stem Cell Transplant in Treating Patients With Persistent or Progressive Cancer

Part of paid clinical trials in La Jolla, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00060372
Phase
PHASE1
Status
Completed

Conditions

  • 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
  • Childhood Myelodysplastic Syndromes
  • Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Disseminated Neuroblastoma
  • Malignant Neoplasm
  • Ovarian Choriocarcinoma
  • Ovarian Embryonal Carcinoma
  • Ovarian Immature Teratoma
  • Ovarian Mature Teratoma
  • Ovarian Mixed Germ Cell Tumor
  • Ovarian Monodermal and Highly Specialized Teratoma
  • Ovarian Polyembryoma
  • Ovarian Yolk Sac Tumor
  • 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
  • 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
  • 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 Teratoma
  • Testicular Yolk Sac Tumor
  • Testicular Yolk Sac Tumor and Teratoma
  • Testicular Yolk Sac Tumor and Teratoma With Seminoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ipilimumab — DRUG
    Given IV
  • therapeutic allogeneic lymphocytes — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Apr 30, 2003
Status verified
Mar 2013
Primary completion
Apr 30, 2008

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ipilmumab and donor lymphocyte infusion)
    Patients receive ipilimumab IV over 90 minutes. Cohorts of 3-6 patients receive escalating doses of ipilimumab until the 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.

Primary Outcome Measure

Incidence of grade 3 and 4 acute GVHD based on NCI CTC [ Time Frame: 60 days following administration of ipilimumab ]

Locations (5)

FacilityCityStateZIPSite coordinators
Scripps Clinic - La JollaLa JollaCalifornia92037-
University of California San DiegoLa JollaCalifornia92093-0960-
Blood and Marrow Transplant Group of GeorgiaAtlantaGeorgia30342-
Northside HospitalAtlantaGeorgia30342-
Dana-Farber Harvard Cancer CenterBostonMassachusetts02115-

Find similar trials in La Jolla, CA

By research site
Scripps Clinic - La Jolla· La Jolla, CAUniversity of California San Diego· La Jolla, CABlood and Marrow Transplant Group of Georgia· Atlanta, GANorthside Hospital· Atlanta, GADana-Farber Harvard Cancer Center· Boston, MA

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