Velcade, Nipent, Rituxan (VNR) in Subjects With Relapsed Follicular, Marginal Zone, and Mantle Cell Lymphoma
Information source: Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Follicular Lymphoma; Marginal Zone Lymphoma; Mantle Cell Lymphoma
Intervention: MTD of Velcade, Nipent and Rituxan established in Part 1 (Drug)
Phase: Phase 1/Phase 2
Status: Terminated
Sponsored by: Louisiana State University Health Sciences Center Shreveport Official(s) and/or principal investigator(s): Francesco Turturro, MD, Principal Investigator, Affiliation: LSUHSC-S
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.
Clinical Details
Official title: Phase 1/2 Study of VELCADE (Bortezomib), Nipent (Pentostatin), and Rituxan (Rituximab) (VNR) in Subjects With Relapsed Follicular, Marginal Zone, and Mantle Cell Lymphoma
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: CR following treatment with VELCADE(bortezomib)/Nipent(pentostatin/Rituxan (rituximab)(VNR) in subjects with follicular lymphoma(FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL)relapsed or refractory after at least 1 prior therapyORR following treatment with VELCADE(bortezomib)/Nipent(pentostatin/Rituxan (rituximab)(VNR) in subjects with follicular lymphoma(FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL)relapsed or refractory after at least 1 prior therapy
Secondary outcome: Maximum Tolerated DoseRate of progression of disease
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 level at which the maximum tolerated dose (MTD) is established.
During the Phase 2 part of the study, approximately 15 subjects will be enrolled in order to
obtain a total 30 response-evaluable subjects.
Study Objectives:
The primary objectives of this study are:
• Assess the CR and ORR following treatment with VELCADE (bortezomib), Nipent (pentostatin)
and Rituxan (rituximab) (VNR) in subjects with follicular lymphoma (FL), marginal zone
lymphoma (MZL), and mantle cell lymphoma (MCL) who have relapsed or been refractory after
receiving at least 1 prior therapy.
The secondary objectives of this study are to:
- Determine the MTD of VELCADE and Nipent in combination with Rituxan (VNR) in subjects
with follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma
(MCL) who have relapsed or been refractory after receiving at least 1 prior therapy
- Evaluate the safety and tolerability of VNR
- Determine the time to response
- Determine duration of response
- Determine the time to progression (TTP)
- Determine the progression free survival (PFS) rate
- Determine the 1-year survival
- Determine overall survival (OS)
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Voluntary written informed consent.
2. Male or female subject 18 years of age and older
3. Karnofsky Performance Status (KPS) score of 50%. ECOG Performance Status score
greater than 2.
4. Histologically confirmed follicular Grade 1-3a, marginal zone or mantle cell NHL.
5. Relapsed or progressive disease after at least 1 prior chemotherapy requiring
treatment.
6. Bi-dimensionally measurable disease with at least 1 lesion 2 cm in a single
dimension
7. Hematologic, hepatic, and renal function parameters.
8. 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
9. Expected survival of 3 months
10. Accepted birth control methods during treatment and for 12 months after completion of
treatment.
Exclusion Criteria:
1. Follicular lymphoma Grade 3b
2. History of allergy to any of the study medications, their analogues, murine proteins,
or excipients in the various formulations
3. Grade 2 peripheral neuropathy or clinical examination within 14 days before
enrollment
4. Serum creatinine 2. 5 mg/dL within 14 days before enrollment.
5. Absolute neutrophil count (ANC) < 1,000/L, platelet count < 70,000/L within 14 days
before enrollment
6. Aspartate transaminase (AST [SGOT]) and alanine transaminase (ALT/SGPT]) > 2 x the
upper limit of normal (ULN), total bilirubin > 3 ULN
7. 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)
8. Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to
Study Day 1 (6 weeks if nitrosurea or mytomycin-C)
9. Prior lymphoma vaccine therapy within 12 months to Study Day 1
10. Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months
prior to Study Day 1
11. Autologous bone marrow or stem cell transplant within 6 months prior to Study Day 1
12. Known history of hepatitis or hepatic disease.
13. Presence of central nervous system (CNS) lymphoma
14. Known history of HIV infection or AIDS
15. Histologic transformation (Follicular or Marginal zone to diffuse large B cell
lymphoma [DLBCL]
16. Presence of pleural or peritoneal effusion with positive cytology for lymphoma
17. Another primary malignancy requiring active treatment
18. 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
19. New York Heart Association Class III or IV (Appendix D) cardiac disease
20. Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1
21. Female subject who is pregnant or currently breast-feeding
22. Received other investigational drugs with 14 days before enrollment
23. Hypersensitivity to bortezomib, pentostatin, rituximab, boron or mannitol.
Locations and Contacts
LSU - Shreveport Health Sciences Center, Feist-Weiller Cancer Center, Shreveport, Louisiana 71103, United States
Additional Information
Starting date: May 2010
Last updated: October 25, 2011
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