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Bortezomib in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

Primary Purpose

Adult Lymphocyte Depletion Hodgkin Lymphoma, Adult Mixed Cellularity Hodgkin Lymphoma, Adult Nodular Sclerosis Hodgkin Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
17-N-allylamino-17-demethoxygeldanamycin/bortezomib
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Lymphocyte Depletion Hodgkin Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically confirmed classical Hodgkin's lymphoma No bone marrow biopsies or fine needle aspirates as the sole means of diagnosis Core biopsies allowed if they contain adequate tissue for primary diagnosis The following subtypes are allowed: Nodular sclerosis Lymphocyte rich Mixed cellularity Lymphocyte depletion Classical Hodgkin's lymphoma, not otherwise specified No nodular lymphocyte-predominant Hodgkin's lymphoma Relapsed or refractory disease after at least 1 prior standard systemic cytotoxic chemotherapy regimen Measurable disease by physical exam or imaging studies Any tumor mass > 1 cm is allowed No non-measurable disease only, including the following: Bone lesions Ascites Pleural or pericardial effusion Lymphangitis cutis/pulmonis Bone marrow No curative option available with high-dose therapy and stem cell transplantation Performance status - 0-2 Absolute neutrophil count ≥ 750/mm^3 Platelet count ≥ 75,000/mm^3 Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST ≤ 2.5 times ULN Creatinine ≤ 2.5 mg/dL No sensory or motor peripheral neuropathy ≥ grade 2 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for up to 3 months after study participation See Disease Characteristics Prior stem cell transplantation allowed See Disease Characteristics No concurrent chemotherapy No concurrent dexamethasone or other steroidal antiemetics Concurrent steroids for adrenal failure allowed Concurrent hormonal therapy for non-disease related conditions (e.g., insulin for diabetes) allowed Prior radiotherapy to a symptomatic lesion or one that may produce disability (e.g., unstable femur) is allowed provided other measurable disease is present No concurrent palliative radiotherapy Recovered from all prior treatment No prior bortezomib or other proteosome inhibitors

Sites / Locations

  • Cancer and Leukemia Group B

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of rapid disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Overall response rate
Time to progression
Overall survival

Secondary Outcome Measures

Full Information

First Posted
May 14, 2004
Last Updated
December 3, 2015
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00082966
Brief Title
Bortezomib in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
Official Title
A Phase II Study of PS-341 (Bortezomib) in Patients With Relapsed or Refractory Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
Phase II trial to study the effectiveness of bortezomib in treating patients who have relapsed or refractory Hodgkin's lymphoma. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the efficacy of bortezomib in patients with relapsed or refractory Hodgkin's lymphoma using overall response rate as the primary efficacy endpoint. II. To assess time to progression and 2-year overall survival after bortezomib therapy. III. To evaluate the safety and tolerability of bortezomib in patients with relapsed/refractory Hodgkin's lymphoma. OUTLINE: This is a multicenter study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of rapid disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Lymphocyte Depletion Hodgkin Lymphoma, Adult Mixed Cellularity Hodgkin Lymphoma, Adult Nodular Sclerosis Hodgkin Lymphoma, Recurrent Adult Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of rapid disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
17-N-allylamino-17-demethoxygeldanamycin/bortezomib
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
Up to 3 years
Title
Time to progression
Time Frame
Up to 5 years
Title
Overall survival
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed classical Hodgkin's lymphoma No bone marrow biopsies or fine needle aspirates as the sole means of diagnosis Core biopsies allowed if they contain adequate tissue for primary diagnosis The following subtypes are allowed: Nodular sclerosis Lymphocyte rich Mixed cellularity Lymphocyte depletion Classical Hodgkin's lymphoma, not otherwise specified No nodular lymphocyte-predominant Hodgkin's lymphoma Relapsed or refractory disease after at least 1 prior standard systemic cytotoxic chemotherapy regimen Measurable disease by physical exam or imaging studies Any tumor mass > 1 cm is allowed No non-measurable disease only, including the following: Bone lesions Ascites Pleural or pericardial effusion Lymphangitis cutis/pulmonis Bone marrow No curative option available with high-dose therapy and stem cell transplantation Performance status - 0-2 Absolute neutrophil count ≥ 750/mm^3 Platelet count ≥ 75,000/mm^3 Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST ≤ 2.5 times ULN Creatinine ≤ 2.5 mg/dL No sensory or motor peripheral neuropathy ≥ grade 2 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for up to 3 months after study participation See Disease Characteristics Prior stem cell transplantation allowed See Disease Characteristics No concurrent chemotherapy No concurrent dexamethasone or other steroidal antiemetics Concurrent steroids for adrenal failure allowed Concurrent hormonal therapy for non-disease related conditions (e.g., insulin for diabetes) allowed Prior radiotherapy to a symptomatic lesion or one that may produce disability (e.g., unstable femur) is allowed provided other measurable disease is present No concurrent palliative radiotherapy Recovered from all prior treatment No prior bortezomib or other proteosome inhibitors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Bartlett
Organizational Affiliation
Cancer and Leukemia Group B
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer and Leukemia Group B
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60606
Country
United States

12. IPD Sharing Statement

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Bortezomib in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

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