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

Completed · Phase 1

Conditions studied: 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

In brief

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 facts

Study ID: NCT00060372
Run by: National Cancer Institute (NCI)
People needed: 21
Starts: 2003-04-01
Last updated by the study team: 2013-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Diagnosis of persistent or progressive hematologic malignancy or solid tumor after allogeneic hematopoietic stem cell transplantation (AHSCT)
Patients are eligible for study entry at any time between post-transplantation day 90 and 3 years after withdrawal of immunosuppressive therapy
Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) that meets any of the following criteria: hematologic relapse by standard criteria, hematologic persistence evidenced by bone marrow blasts > 10% after day 30 post-AHSCT
Cytogenetic progression as evidenced by an increase in the percentage of Philadelphia chromosome (Ph)1-positive metaphases (or Ph1-positive cells by fluorescent in situ hybridization) from complete cytogenetic response (0% Ph1-positive cells) to partial response (1-34% Ph1-positive cells); PR to minor response (35-94% Ph1-positive cells); or MR to no response (95-100% Ph1-positive cells)
Resistance to imatinib mesylate, defined as disease progression (hematologic, cytogenetic, or molecular) during OR failure to respond to (i.e., lack of complete hematologic response after 3 months, lack of partial cytogenetic response after 6 months, or lack of complete cytogenetic response after 12 months) prior imatinib mesylate therapy
Myelodysplastic syndromes that meet any of the following criteria:
Hematologic relapse by standard criteria, cytogenetic relapse evidenced by recurrence of clonal abnormality in patients who achieved CCR after AHSCT, hematologic persistence evidenced by cytopenias not attributable to other post-transplant causes accompanied by characteristic morphological changes more than 90 days after AHSCT
OR; Hematologic persistence evidenced by cytopenias not attributable to other post-transplant causes accompanied by characteristic morphological changes more than 90 days after AHSCT, or cytogenetic persistence evidenced by persistence of clonal abnormality more than 90 days after AHSCT
Chronic lymphocytic leukemia that meets any of the following criteria:
greater than 25% increase in absolute lymphocytosis of > 5,000/mm3, greater than 25% increase in measurable lymphadenopathy, persistence of absolute lymphocytosis of > 5,000/mm3 at day 90 or later after AHSCT, persistence of lymphadenopathy of ≥ 3 cm in diameter at day 90 or later after AHSCT
Aggressive non-Hodgkin's lymphoma (e.g., diffuse large cell lymphoma, lymphoblastic lymphoma, mantle cell lymphoma, or peripheral T cell lymphoma), Hodgkin's lymphoma, OR solid tumor that meets any of the following criteria: greater than 50% increase in measurable or evaluable disease, persistence of measurable lesions > 3.0 cm in diameter at day 90 or later after AHSCT OR;
Persistence of malignancy by biopsy or positron emission tomography scan unless there is clear evidence of progression
Multiple myeloma with demonstrated resistance to or intolerance of prior thalidomide and bortezomib unless these agents are contraindicated (e.g., due to peripheral neuropathy) and meeting any of the following criteria: greater than 25% increase in paraprotein band, abnormal quantitative immunoglobulin level, or urine protein excretion OR
Greater than 25% increase in percent of plasma cells in the bone marrow (if > 15%), presence of new lytic bone lesions, new extramedullary lesions OR ≥ 25% enlargement of existing extramedullary lesions, persistence of paraprotein band, abnormally elevated quantitative immunoglobulin level, or bone marrow plasmacytosis > 15% for a period of at least 90 days after AHSCT
At least 1 bidimensionally measurable lesion ≥ 1.5 cm in diameter
Evaluable disease is defined as disease that is assessable for response (e.g., pleural effusion, elevated serum tumor)
Bone metastases that can be assessed by CT scan or MRI considered evaluable
Leukemia is considered evaluable disease
Patients who met criteria for persistence or progression with AML, ALL, CML, or aggressive NHL AND are currently in complete remission after reinduction therapy do not require measurable or evaluable disease to be eligible
At least 50% donor chimerism in the T-cell lineage OR full (≥ 90%) donor chimerism in unseparated blood on last assessment within 3 months before study entry
No evidence on consecutive testing of > 10% decline in T-cell chimerism beyond the error of the test
ECOG 0-2
Life expectancy: More than 3 months
No prior grade 3 or 4 acute graft-vs-host disease
No concurrent autoimmune diseases requiring the chronic use of immunosuppressive medications, active connective tissue disease, CNS disease including multiple sclerosis or demyelinating disease, inflammatory bowel disease, autoimmune hepatitis

Where it is running

Scripps Clinic - La Jolla — La Jolla, California, United States
University of California San Diego — La Jolla, California, United States
Blood and Marrow Transplant Group of Georgia — Atlanta, Georgia, United States
Northside Hospital — Atlanta, Georgia, United States
Dana-Farber Harvard Cancer Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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