• Response rate after 2-4 courses [ Designated as safety issue: No ]
  

OBJECTIVES:

• Determine the feasibility and safety of gemcitabine, carboplatin, and dexamethasone with or without rituximab, in terms of response rate, in patients with relapsed or primary refractory lymphoid malignancy.
• Determine the efficacy of these regimens in these patients.
• Determine the impact of these regimens on stem cell reserve in these patients.
• Determine the remission duration in patients treated with these regimens.

OUTLINE: This is a pilot study. Patients are stratified according to CD20 expression (negative vs positive).

• Stratum I (CD20 negative): Patients receive carboplatin IV over 30 minutes on day 1; gemcitabine IV over 30 minutes on days 1 and 8; and oral dexamethasone on days 1-4.
• Stratum II (CD20 positive): Patients receive carboplatin, gemcitabine, and dexamethasone as in stratum I and rituximab IV on day 8.

In both strata, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 5 years.

PROJECTED ACCRUAL: Approximately 51 patients will be accrued for this study within 2-3 years.

DISEASE CHARACTERISTICS:

• Diagnosis of relapsed or primary refractory lymphoid malignancy, with REAL or WHO classification provided, including the following types:

  • B-cell lymphoma
  • T-cell lymphoma
  • Hodgkin's lymphoma
• No disease refractory (i.e., not responded or progressed within 6 months) to a carboplatin- or cisplatin-based regimen or a gemcitabine-based regimen

• Bidimensionally measurable disease by CT chest/abdomen/pelvis within 28 days of enrollment

  • At least 1 cm by CT scan, MRI, medical photograph (skin or oral lesion), plain x-ray, or other conventional techniques OR at least 2 cm by palpation

• Bone marrow aspirate and biopsy within the past 28 days

  • No prior anticancer therapy during the interval between bone marrow aspirate and biopsy and study entry
• No active CNS lymphoma

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• SWOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Patients with cytopenia due to disease in bone marrow that do not meet these criteria may be enrolled at the Study Chair's discretion

Hepatic

• Bilirubin less than 2 times upper limit of normal (ULN)
• No active HBV infection or hepatitis

Renal

• Creatinine less than 1.5 times ULN
• Creatine clearance greater than 50 mL/min

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 6 months after study participation
• HIV negative
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No other medical condition that would preclude study treatment
• Must be anticipated to complete at least 2 courses of therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified