Flavopiridol in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma
Stopped early · Phase 1/Phase 2
Conditions studied: Adult Lymphocyte Depletion Hodgkin Lymphoma, Adult Lymphocyte Predominant Hodgkin Lymphoma, Adult Mixed Cellularity Hodgkin Lymphoma, Adult Nodular Sclerosis Hodgkin Lymphoma, 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 Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Hodgkin 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 Multiple Myeloma, Splenic Marginal Zone Lymphoma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma, Waldenström Macroglobulinemia
In brief
This phase I/II trial is studying the side effects and best dose of flavopiridol and to see how well it works in treating patients with lymphoma or multiple myeloma. Drugs used in chemotherapy, such as flavopiridol, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Key facts
- Study ID
- NCT00112723
- Run by
- National Cancer Institute (NCI)
- People needed
- 46
- Starts
- 2005-12-01
- Expected to finish
- 2015-11-01
- Last updated by the study team
- 2016-08-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of 1 of the following hematologic malignancies:
- Hodgkin's lymphoma
- Non-Hodgkin's lymphoma (NHL)
- Multiple myeloma
- Patients in the phase II portion of the study are enrolled in 1 of the following strata according to diagnosis*
- Stratum 1: Indolent B-cell NHL (non-Hodgkin's lymphoma), follicle center B-cell NHL (grade 1, 2, or 3), marginal zone lymphoma, Waldenstrom's macroglobulinemia, or small lymphocytic lymphoma (without blood lymphocytosis at any point in the disease process)
- Must have progressive lymphadenopathy, worsening cytopenias, or progressive symptoms attributed to lymphoma
- Must require therapy, as determined by progressive anemia, thrombocytopenia, symptoms (e.g., fever, night sweats, weight loss, or fatigue), or progressive lymphadenopathy that causes discomfort
- Received ≥ 2 prior therapies, including rituximab
- Stratum 1a: Hairy cell leukemia
- Must require therapy, as determined by progressive cytopenias or symptoms (fever, night sweats, weight loss, or fatigue)
- Must have received ≥ 2 therapies
- Stratum 2: Mantle cell lymphoma, as determined by the presence of cyclin D1 staining OR t(11;14)
- Stratum 3: Intermediate grade B-cell NHL, including diffuse large B-cell NHL and T-cell rich B-cell NHL
- Diffuse large B-cell NHL arising from an indolent NHL (i.e., transformed lymphoma) allowed
- Ineligible for potentially curative autologous stem cell transplantation
- Stratum 4: T-cell and natural killer-cell NHL, including anaplastic large cell lymphoma and peripheral T-cell NHL
- Primary cutaneous lymphoma or Sezary syndrome allowed provided criteria for measurable disease are met
- Received ≥ 1 prior systemic therapy
- Stratum 5: Hodgkin's lymphoma
- Any of the following subtypes are allowed:
- Nodular sclerosing
- Mixed cellularity
- Lymphocyte predominant
- Lymphocyte depleted
Where it is running
- Ohio State University Medical Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.