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

Recurrent Adult Hodgkin Lymphoma Clinical Trial

Official title:

A Phase II Study of PS-341 (Bortezomib) in Patients With Relapsed or Refractory Hodgkin's Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00082966
• Other study ID #: NCI-2012-01812
• Secondary ID: CALGB-50206CDR00
• Status: Completed
• Phase: Phase 2
• First received: May 14, 2004
• Last updated: December 3, 2015
• Start date: March 2004

Study information

• Verified date: June 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adult Lymphocyte Depletion Hodgkin Lymphoma
• Adult Mixed Cellularity Hodgkin Lymphoma
• Adult Nodular Sclerosis Hodgkin Lymphoma
• Hodgkin Disease
• Lymphoma
• Recurrent Adult Hodgkin Lymphoma

Intervention

Drug:
• 17-N-allylamino-17-demethoxygeldanamycin/bortezomib
Given IV

Locations

Country	Name	City	State
United States	Cancer and Leukemia Group B	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		Up to 3 years	No
Primary	Time to progression		Up to 5 years	No
Primary	Overall survival		2 years	No