Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Adult Lymphocyte Depletion Hodgkin Lymphoma, Adult Mixed Cellularity Hodgkin Lymphoma, Adult Nodular Sclerosis Hodgkin Lymphoma, Recurrent Adult Hodgkin Lymphoma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall response rate

Outcome Time Frame:

Up to 3 years

Safety Issue:

No

Principal Investigator

Nancy Bartlett

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01812

NCT ID:

NCT00082966

Start Date:

March 2004

Completion Date:

Related Keywords:

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

Name

Location

Cancer and Leukemia Group BChicago, Illinois  60606