Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Mantle-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Mantle Cell Lymphoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Rituximab

Bortezomib

Antineoplastic Agents, Immunological

Immunologic Factors

Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles

Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)

VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by a dose escalation schedule.

Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)

VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:

Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4

Bortezomib, CHOP, Rituximab

John P Leonard, MD

Primary Objective:

To determine the toxicity profile and maximum tolerated dose (MTD) of VELCADE when administered in combination with CHOP + Rituximab to patients with previously untreated diffuse large B cell or mantle cell non-Hodgkin's lymphoma (NHL)

Secondary Objectives:

To assess the response rate (overall and complete), event-free survival and overall survival with VELCADE and CHOP-R in patients with previously untreated diffuse large B cell or mantle cell lymphoma (phase II component)

Treatment:

Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles

Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)

VELCADE is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:

Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4

Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles

Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)

VELCADE is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:

Once completed six cycles of therapy (\~18 weeks), patients will be evaluated every 3 months for the first year post treatment, then every 6 months until disease progression or death for years 2 through 5 post treatment. Patients who have disease progression will be contacted every 6 months until death to assess for survival status.

Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles

Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)

VELCADE is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the dose escalation schedule.

Phase I/II Trial of VELCADE + CHOP-Rituximab in Untreated DLCBL or Mantle Cell NHL

Phase I/II Trial of VELCADE+ CHOP-Rituximab in Patients With Previously Untreated Diffuse Large B Cell or Mantle Cell Non-Hodgkin's Lymphoma

Millennium Pharmaceuticals, Inc.

Weill Medical College of Cornell University

Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles

Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)

VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by a dose escalation schedule.

Bortezomib, CHOP, Rituximab: Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)

VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:

Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4

Arm 1

with untreated Diffuse Large B-cell Lymphoma (n = 40)

Untreated DLBCL

with untreated mantle cell Non-Hodgkin's Lymphoma

Untreated MCL

Total

Age, Continuous

Sex: Female, Male

John Leonard, MD

Overall Study

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Pharmaceutical Solutions

Dexamethasone

Etoposide

Cisplatin

Ifosfamide

Dexamethasone acetate

Etoposide phosphate

Isophosphamide mustard

Mesna

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

VIPER chemotherapy will be administered every 28 days at the following doses:

* Dexamethasone 40 mg IV days 1-4
* Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4
* Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)
* Cisplatin 25 mg IV days 1-4
* Etoposide 100 mg/m2 CIVI over 24 hours days 1-4
* Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)
* VELCADE 1.5 mg/m2 on days 2 and 5

bortezomib, dexamethasone, ifosfamide

mesna, cisplatin, etoposide, rituximab

Richard Furman, MD

Objectives

The primary objective of this study is to:

• determine the complete and partial response rates and the toxicity profile of bortezomib (VELCADE, formerly PS-341) when administered in combination with DICE chemotherapy plus rituximab (i.e. VIPER) to patients with relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma

The secondary objectives of this study are to:

* assess event free survival and overall survival
* assess conversion of chemo-resistant to chemo-sensitive disease
* assess the ability to collect stem cells from patients treated with salvage VIPER who then undergo autologous stem cell transplantation
* perform correlative studies on pre-treatment tumor biopsy specimens; analyses will include the assessment of immunohistochemical expression patterns (germinal center B cell vs. activated B cell) and NF-κB activity

Single arm phase II trial of combination therapy bortezomib, DICE, and Rituximab in patients with relapsed and refractory diffuse large B-cell non-Hodgkin's lymphoma (NHL)

VIPER chemotherapy will be administered every 28 days at the following doses:

* Dexamethasone 40 mg IV days 1-4
* Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4
* Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)
* Cisplatin 25 mg IV days 1-4
* Etoposide 100 mg/m2 CIVI over 24 hours days 1-4
* Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)
* VELCADE 1.5 mg/m2 on days 2 and 5

Phase II Study of "VIPER" Chemotherapy in Rel/Ref DLBCL

Phase II Trial of "VIPER" Chemotherapy in Relapsed and Refractory Diffuse Large B-cell Lymphoma (NHL)

Study Treatment

Complete Response

This is a single arm study

bortezomib, dexamethasone, ifosfamide: VIPER chemotherapy will be administered every 28 days at the following doses:

* Dexamethasone 40 mg IV days 1-4
* Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4
* Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)
* Cisplatin 25 mg IV days 1-4
* Etoposide 100 mg/m2 CIVI over 24 hours days 1-4
* Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)
* VELCADE 1.5 mg/m2 on days 2 and 5

mesna, cisplatin, etoposide, rituximab: VIPER chemotherapy will be administered every 28 days at the following doses:

* Dexamethasone 40 mg IV days 1-4
* Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4
* Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)
* Cisplatin 25 mg IV days 1-4
* Etoposide 100 mg/m2 CIVI over 24 hours days 1-4
* Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)
* VELCADE 1.5

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Patients with relapsed or refractory mantle cell lymphoma

Patients with relapsed or refractory diffuse large B cell lymphoma

Patients with relapsed or refractory multiple myeloma

30 min. intravenous infusion of canfosfamide HCl (1000 mg/m2) every 2 weeks

Canfosfamide HCl for injection

Joseph Bertino, MD

This is a Phase 2 study to determine the efficacy and safety of canfosfamide treatment in relapsed or refractory mantle cell lymphoma, diffuse large B cell lymphoma and multiple myeloma. The study will be conducted in two stages with 5-6 patients in each indication in Stage 1 and if responses are observed an additional 10 patients in Stage 2 in each group.

Study of Canfosfamide in Refractory or Relapsed Mantle Cell, Diffuse Large B Cell Lymphoma and Multiple Myeloma

Phase 2 Study of Canfosfamide HCl for Injection (Telcyta®, TLK286)in Refractory or Relapsed Mantle Cell Lymphoma (MCL), Diffuse Large B Cell Lymphoma (DLBCL) and Multiple Myeloma (MM)

Disease will be assessed every 6 weeks using International Working Group Response Criteria for Non-Hodgkins Lymphoma in the mantle cell and diffuse large B cell lymphoma patients and the International Myeloma Working Group Response Criteria for multiple myeloma patients. Patients will continue to be treated and disease assessed until disease progression or unacceptable toxicity.

Duration of response will be determined after disease progression is documented in patients who have an objective response.

Toxicity will be assessed throughout study using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0.

Telik

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I/II Trial of VELCADE + CHOP-Rituximab in Untreated DLCBL or Mantle Cell NHL	NCT00151320	Non-Hodgkin's L...	Bortezomib, CHO...	18 Years -	Weill Medical College of Cornell University
Phase II Study of "VIPER" Chemotherapy in Rel/Ref DLBCL	NCT00504751	Non-Hodgkin's L...	bortezomib, dex... mesna, cisplati...	18 Years -	Weill Medical College of Cornell University
Study of Canfosfamide in Refractory or Relapsed Mantle Cell, Diffuse Large B Cell Lymphoma and Multiple Myeloma	NCT01148108	Mantle Cell Lym... B Cell Lymphoma Multiple Myelom...	Canfosfamide HC...	18 Years -	Telik

Spots Global Cancer Trial Database for diffuse large b cell