Alvocidib in Treating Patients With Metastatic or Unresectable Refractory Solid Tumors or Hematologic Malignancies
Stopped early · Phase 1
Conditions studied: Hematopoietic/Lymphoid Cancer, Unspecified Adult Solid Tumor, Protocol Specific
In brief
This phase I trial is studying the side effects and best dose of alvocidib in treating patients with metastatic or unresectable refractory solid tumors or hematologic malignancies. Drugs used in chemotherapy, such as alvocidib, work in different ways to stop cancer cells from dividing so they stop growing or die.
Key facts
- Study ID
- NCT00070239
- Run by
- National Cancer Institute (NCI)
- People needed
- 100
- Starts
- 2003-08-01
- Last updated by the study team
- 2013-12-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed malignancy, including the following types:
- Hematologic malignancy, including any of the following: (Accrual for patients with hematologic malignancies temporarily closed as of 11/30/04)
- Mantle cell lymphoma
- Morphologically confirmed disease
- CD20 and CD5 positive
- Any other refractory lymphoma
- Chronic lymphocytic leukemia
- Rai stage III or IV and meeting at least 1 of the following criteria for active disease:
- Weight loss > 10% in the last 6 months
- Fatigue
- Fever or night sweats with no evidence of infection
- Progressive anemia or thrombocytopenia
- Progressive lymphocytosis with a lymphocyte doubling time of < 6 months
- Marked hypogammaglobulinemia or paraproteinemia
- Progressive splenomegaly and/or lymphadenopathy
- Multiple myeloma
- Disease confirmed by bone marrow aspirate and/or biopsy
- Relapsed or refractory disease after the most recent treatment regimen
- Quantifiable monoclonal immunoglobulin in serum and/or urine
- Solid tumor, including but not limited to any of the following:
- Breast cancer
- Histologically or cytologically confirmed stage IV invasive disease
- HER-2 positivity not required for study enrollment
- Tumor overexpressing HER-2 should be confirmed by immunohistochemistry OR fluorescence in situ hybridization
- Small cell lung cancer
Where it is running
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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