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Phase II Pilot Study of Bortezomib (VELCADE®) and Gemcitabine for Patients With Relapsed or Refractory Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

Phase II Pilot Study of Bortezomib (VELCADE®) and Gemcitabine for Patients With Relapsed or Refractory Hodgkin's Lymphoma


OBJECTIVES:

Primary

- Determine the overall response rate (partial and complete response) in patients with
relapsed or refractory Hodgkin's lymphoma treated with bortezomib and gemcitabine
hydrochloride.

Secondary

- Determine the safety and toxic effects of this regimen in these patients.

- Determine the time to progression in patients treated with this regimen.

- Correlate NF-kB inhibition and proteasome activity with response in patients treated
with this regimen.

OUTLINE: This is a multicenter, pilot study.

Patients receive bortezomib IV on days 1, 4, 8, and 11 and gemcitabine hydrochloride IV over
30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 2 years and then
annually thereafter.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed Hodgkin's lymphoma

- Recurrent or refractory disease after prior standard combination chemotherapy

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 1 cm by
physical exam or imaging studies

- No history of non-Hodgkin's lymphoma

- No history of other hematological malignancy

PATIENT CHARACTERISTICS:

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Platelet count ≥ 100,000/mm^3

- Absolute neutrophil count ≥ 1,000/mm^3

Hepatic

- Bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert's disease or
involvement by Hodgkin's lymphoma)

- AST ≤ 3 times ULN (unless due to involvement by Hodgkin's lymphoma)

Renal

- Creatinine clearance ≥ 30 mL/min

Cardiovascular

- Ejection fraction ≥ 40% by MUGA or echocardiogram (in patients with a history of
cardiac disease)

Pulmonary

- Must not require supplemental oxygen therapy

Immunologic

- No known HIV infection

- No uncontrolled bacterial, viral, or fungal infection

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignancy requiring therapy

- No peripheral neuropathy ≥ grade 2 within the past 14 days

- No hypersensitivity to boron

- No hypersensitivity to mannitol

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 30 days since prior monoclonal antibody therapy for Hodgkin's lymphoma

- More than 6 months since prior autologous stem cell transplantation

- No prior allogeneic stem cell transplantation

- No concurrent sargramostim (GM-CSF)

- No concurrent pegfilgrastim or filgrastim (G-CSF)

- No concurrent interleukin-11(oprelvekin)

Chemotherapy

- See Disease Characteristics

- More than 30 days since prior chemotherapy for Hodgkin's lymphoma

- No prior treatment with gemcitabine hydrochloride

Endocrine therapy

- More than 30 days since prior corticosteroid therapy for Hodgkin's lymphoma

- No concurrent corticosteroid therapy

Radiotherapy

- More than 30 days since prior radiotherapy for Hodgkin's lymphoma

Other

- No prior treatment with bortezomib

- More than 14 days since prior investigational drugs

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Response rate after 2 courses of therapy

Safety Issue:

No

Principal Investigator

Jonathan W. Friedberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James P. Wilmot Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000448635

NCT ID:

NCT00262860

Start Date:

April 2005

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

Name

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642