17-N-Allylamino-17-Demethoxygeldanamycin and Bortezomib in Treating Patients With Relapsed or Refractory Hematologic Cancer
Stopped early · Phase 1
Conditions studied: Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, Waldenström Macroglobulinemia
In brief
This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin and bortezomib in treating patients with relapsed or refractory hematologic cancer. Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving 17-N-allylamino-17-demethoxygeldanamycin together with bortezomib may kill more cancer cells.
Key facts
- Study ID
- NCT00103272
- Run by
- National Cancer Institute (NCI)
- People needed
- 74
- Starts
- 2005-04-01
- Last updated by the study team
- 2013-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed diagnosis of 1 of the following hematologic malignancies:
- Acute myeloid leukemia or acute lymphoblastic leukemia
- Not a candidate for potentially curative therapy
- WBC ≤ 10,000/mm\^3 OR WBC ≤ 40,000/mm\^3 that is stable for 5 days (hydroxyurea allowed)
- No acute promyelocytic leukemia
- Non-Hodgkin's lymphoma (NHL), including 1 of the following subtypes:
- Small lymphocytic lymphoma
- Marginal zone lymphoma
- Lymphoplasmacytic lymphoma
- Follicular lymphoma
- Mantle cell lymphoma
- Diffuse large B-cell lymphoma
- Anaplastic large cell lymphoma
- Peripheral T-cell lymphoma
- Extranodal NK/T cell lymphoma (nasal and nasal type)
- Enteropathy-type T-cell lymphoma
- Hepatosplenic T-cell lymphoma
- Angioimmunoblastic T-cell lymphoma
- Subcutaneous panniculitis-like T-cell lymphoma
- Chronic lymphocytic leukemia (CLL)
- Patients with NHL or CLL must meet the following criteria:
- Ineligible for, or refused potentially curative stem cell transplantation
- Transformed lymphoma/Richter's transformation, defined as the transformation of low-grade lymphoma, including follicular lymphoma, CLL, or small lymphocytic lymphoma to high-grade lymphoma (i.e., diffuse large cell lymphoma) allowed at time of transformation
- Evidence of ≥ 50% bone marrow involvement at the time of enrollment OR tumor tissue accessible for biopsy (for patients enrolled after the maximum tolerated dose [MTD] is determined)
- Absolute neutrophil count ≥ 1,000/mm\^3
Where it is running
- Ohio State University Medical Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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