RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and dexamethasone, use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, carboplatin, and dexamethasone with or without rituximab in treating patients who have relapsed or primary refractory lymphoma.

Condition	Treatment or Intervention	Phase
Hodgkin's lymphoma adult T-cell leukemia and lymphoma anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma Cutaneous T-Cell Lymphoma Non-Hodgkin's Lymphoma	Drug: carboplatin  Drug: dexamethasone  Drug: gemcitabine  Drug: rituximab  Procedure: antibody therapy  Procedure: biological response modifier therapy  Procedure: chemotherapy  Procedure: monoclonal antibody therapy	Phase II

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of relapsed or primary refractory lymphoid malignancy, 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
• 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

Hepatic

• Bilirubin less than 2 times upper limit of normal (ULN)

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

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Washington
      Seattle Cancer Care Alliance, Seattle,  Washington,  98109,  United States; Recruiting

Study chairs or principal investigators

Ajay K. Gopal, MD,  Study Chair,  Seattle Cancer Care Alliance   
John Pagel, MD, PhD,  Fred Hutchinson Cancer Research Center   

Study ID Numbers:  CDR0000339814; UW-LYM.03.01; PSOC-2003; LILLY-B9E-US-X348
Record last reviewed:  October 2003
Record first received:  November 4, 2003
ClinicalTrials.gov Identifier:  NCT00072514
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-18