Status:
WITHDRAWN
Velcade, Nipent, Rituxan (VNR) in Subjects With Relapsed Follicular, Marginal Zone, and Mantle Cell Lymphoma
Lead Sponsor:
Louisiana State University Health Sciences Center Shreveport
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Follicular Lymphoma
Marginal Zone Lymphoma
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a phase 1/2 Study of VELCADE (bortezomib), Nipent (pentostatin), and Rituxan (rituximab) (VNR) in Subjects with Relapsed Follicular, Marginal Zone, and Mantle Cell Lymphoma.
Detailed Description
Number of Subjects: During the Phase 1 part of the study as many as 15 subjects may be enrolled, based on the dose escalation scheme; the actual number of subjects enrolled will depend on the dose lev...
Eligibility Criteria
Inclusion
- Voluntary written informed consent.
- Male or female subject 18 years of age and older
- Karnofsky Performance Status (KPS) score of 50%. ECOG Performance Status score greater than 2.
- Histologically confirmed follicular Grade 1-3a, marginal zone or mantle cell NHL.
- Relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment.
- Bi-dimensionally measurable disease with at least 1 lesion 2 cm in a single dimension
- Hematologic, hepatic, and renal function parameters.
- Recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, autologous bone marrow or stem cell transplant, or investigational drugs
- Expected survival of 3 months
- Accepted birth control methods during treatment and for 12 months after completion of treatment.
Exclusion
- Follicular lymphoma Grade 3b
- History of allergy to any of the study medications, their analogues, murine proteins, or excipients in the various formulations
- Grade 2 peripheral neuropathy or clinical examination within 14 days before enrollment
- Serum creatinine 2.5 mg/dL within 14 days before enrollment.
- Absolute neutrophil count (ANC) \< 1,000/L, platelet count \< 70,000/L within 14 days before enrollment
- Aspartate transaminase (AST \[SGOT\]) and alanine transaminase (ALT/SGPT\]) \> 2 x the upper limit of normal (ULN), total bilirubin \> 3 ULN
- Rituxan refractory or refractory to anti-CD20 radioimmunotherapy (no response to prior Rituxan or prior Rituxan-containing regimen, or a response with a TTP of less than 6 months)
- Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to Study Day 1 (6 weeks if nitrosurea or mytomycin-C)
- Prior lymphoma vaccine therapy within 12 months to Study Day 1
- Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to Study Day 1
- Autologous bone marrow or stem cell transplant within 6 months prior to Study Day 1
- Known history of hepatitis or hepatic disease.
- Presence of central nervous system (CNS) lymphoma
- Known history of HIV infection or AIDS
- Histologic transformation (Follicular or Marginal zone to diffuse large B cell lymphoma \[DLBCL\]
- Presence of pleural or peritoneal effusion with positive cytology for lymphoma
- Another primary malignancy requiring active treatment
- Serious non-malignant disease (e.g., congestive heart failure \[CHF\], hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions (including psychiatric), which would compromise protocol objectives n the opinion of the Investigator and/or Sponsor
- New York Heart Association Class III or IV (Appendix D) cardiac disease
- Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1
- Female subject who is pregnant or currently breast-feeding
- Received other investigational drugs with 14 days before enrollment
- Hypersensitivity to bortezomib, pentostatin, rituximab, boron or mannitol.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01460602
Start Date
May 1 2010
End Date
October 1 2014
Last Update
September 1 2020
Active Locations (1)
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1
LSU - Shreveport Health Sciences Center, Feist-Weiller Cancer Center
Shreveport, Louisiana, United States, 71103