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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with gemcitabine hydrochloride may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with gemcitabine hydrochloride works in treating patients with relapsed or refractory Hodgkin's lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Treatments: Bortezomib; Gemcitabine

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