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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 April 2013 |
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Main ID: |
NCT00082784 |
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Date of registration:
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14/05/2004 |
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Primary sponsor: |
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Public title:
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Bortezomib and Flavopiridol in Treating Patients With Recurrent or Refractory Indolent B-Cell Neoplasms
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Scientific title:
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Phase I Trial of Bortezomib (PS-341; NSC 681239) and Alvocidib (Flavopiridol NSC 649890) in Patients With Recurrent or Refractory Indolent B-cell Neoplasms |
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Date of first enrolment:
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March 2004 |
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Target sample size:
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60 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00082784 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Steven Grant |
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Address:
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Telephone:
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Email:
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Affiliation:
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H. Lee Moffitt Cancer Center and Research Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- WBC < 50,000/mm^3 for patients with circulating tumor cells
- No prior allergic reaction to compounds of similar chemical or biological composition
to and presumably able to tolerated bortezomib, flavopiridol, allopurinol, sodium
polystyrene sulfonate, or dexamethasone
- No neuropathy >= grade 2
- No other condition that would preclude study participation
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 3 months after study
participation
- Prior autologous stem cell transplantation is allowed
- No prior allogeneic stem cell transplantation
- No other concurrent anticancer agents
- No other concurrent investigational agents
- Hemoglobin >= 8 g/dL
- Platelet count >= 100,000/mm^3
- Absolute neutrophil count >= 1,500/mm^3
- Bilirubin =< 2 times upper limit of normal (ULN)
- AST/ALT =< 3 times ULN
- Creatinine =< 2 times ULN or Creatinine clearance >= 50 mL/min
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
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Nodal Marginal Zone B-cell Lymphoma
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Recurrent Adult Diffuse Large Cell Lymphoma
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Recurrent Adult Diffuse Mixed Cell Lymphoma
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Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
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Recurrent Grade 1 Follicular Lymphoma
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Recurrent Grade 2 Follicular Lymphoma
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Recurrent Grade 3 Follicular Lymphoma
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Recurrent Mantle Cell Lymphoma
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Recurrent Marginal Zone Lymphoma
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Refractory Multiple Myeloma
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Splenic Marginal Zone Lymphoma
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Waldenström Macroglobulinemia
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Intervention(s)
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Drug: alvocidib
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Drug: bortezomib
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Other: pharmacological study
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Primary Outcome(s)
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Recommended phase II dose
[Time Frame: 21 days]
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Secondary Outcome(s)
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Maximum tolerated dose, assessed according to NCI CTCAE v4.0
[Time Frame: 21 days]
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Response
[Time Frame: Up to 8 years]
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Response duration
[Time Frame: Up to 8 years]
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Survival
[Time Frame: Up to 8 years]
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Time to progression
[Time Frame: Up to 8 years]
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Secondary ID(s)
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CDR0000360816
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MCC 6413
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MCC-6413
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N01CM00100
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NCI-2009-00058
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R21CA110953
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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