RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have Hodgkin's disease or non-Hodgkin's lymphoma that has not responded to previous treatment.

Condition	Treatment or Intervention	Phase
recurrent grade III follicular large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma recurrent adult diffuse mixed cell lymphoma recurrent mantle cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult Hodgkin's disease	Procedure: chemotherapy  Drug: cisplatin  Drug: dexamethasone  Drug: gemcitabine	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the efficacy of gemcitabine, dexamethasone, and cisplatin in patients with relapsed or refractory Hodgkin's disease or aggressive non-Hodgkin's lymphoma. II. Determine the qualitative and quantitative toxicity of this regimen in these two patient populations.

PROTOCOL OUTLINE: This is a multicenter study. Patients are stratified according to disease (Hodgkin's disease vs non-Hodgkin's lymphoma). Patients receive oral dexamethasone on days 1-4, cisplatin IV over 1 hour on day 1, and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks, 3 months, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 44-88 patients (22-44 per stratum) will be accrued for this study within 4-10 months.

Ages Eligible for Study:  16 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Histologically or cytologically confirmed Hodgkin's disease

OR

Histologically or cytologically confirmed aggressive non-Hodgkin's lymphoma (NHL) of B-cell origin (including immunoblastic, anaplastic large cell, mediastinal large B-cell, or T-cell rich B-cell NHL)

• No prior diagnosis of low-grade NHL
• No histologic evidence of transformation from indolent to aggressive histology

Bidimensionally measurable disease that is clinically or radiologically documented

• Bone lesions not considered bidimensionally measurable
• Lymph nodes at least 1.5 cm by 1.5 cm OR
• Other non-nodal lesions at least 1 cm by 1 cm

Recurrent or refractory to at least 1 prior chemotherapy regimen (excluding gemcitabine and cisplatin)

No known CNS involvement

--Prior/Concurrent Therapy--

Biologic therapy:

• No prior stem cell transplantation
• No concurrent monoclonal antibody therapy
• No concurrent growth factors during the first course of study

Chemotherapy:

• See Disease Characteristics
• At least 4 weeks since prior IV chemotherapy
• No prior cisplatin or gemcitabine
• No prior high-dose chemotherapy
• No other concurrent cytotoxic therapy

Endocrine therapy: No concurrent corticosteroids, except for physiologic replacement

Radiotherapy:

• No prior radiotherapy to more than 25% of functioning bone marrow
• At least 4 weeks since prior radiotherapy and recovered
• No concurrent radiotherapy

Surgery: At least 2 weeks since prior major surgery

Other: No other concurrent anti-cancer therapy or experimental therapy

--Patient Characteristics--

Age: 16 and over

Performance status: ECOG 0-2

Life expectancy: At least 12 weeks

Hematopoietic:

• Absolute granulocyte count at least 1,500/mm3
• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST or ALT no greater than 2.5 times ULN

Renal: Creatinine less than 1.6 mg/dL

Cardiovascular: No significant cardiac dysfunction or cardiovascular disease

Other:

• HIV negative
• No other concurrent or prior malignancy within the past 5 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
• No other serious illness or medical condition that would preclude study
• No active uncontrolled bacterial, fungal, or viral infection
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada
      Tom Baker Cancer Center - Calgary, Calgary,  Alberta,  T2N 4N2,  Canada
Canada, New Brunswick
      Moncton Hospital, Moncton,  New Brunswick,  E1C 6ZB,  Canada
Canada, Newfoundland and Labrador
      Newfoundland Cancer Treatment and Research Foundation, St. Johns,  Newfoundland and Labrador,  A1B 3V6,  Canada
Canada, Ontario
      Cancer Care Ontario - Windsor Regional Cancer Centre, Windsor,  Ontario,  N8W 2X3,  Canada
      Cancer Care Ontario-Hamilton Regional Cancer Centre, Hamilton,  Ontario,  L8V 5C2,  Canada
      Cancer Care Ontario-London Regional Cancer Centre, London,  Ontario,  N6A 4L6,  Canada
      Credit Valley Hospital, Mississauga,  Ontario,  L5M 2N1,  Canada
      Humber River Regional Hospital, Weston,  Ontario,  M9N 1N8,  Canada
      Kingston Regional Cancer Centre, Kingston,  Ontario,  K7L 5P9,  Canada
      Northwestern Ontario Regional Cancer Centre, Thunder Bay, Thunder Bay,  Ontario,  P7A 7T1,  Canada
      Princess Margaret Hospital, Toronto,  Ontario,  M5G 2M9,  Canada
      Toronto Sunnybrook Regional Cancer Centre, Toronto,  Ontario,  M4N 3M5,  Canada

Study chairs or principal investigators

Michael Crump,  Study Chair,  National Cancer Institute of Canada   

Study ID Numbers:  CDR0000068518; CAN-NCIC-LY10; LILLY-CAN-NCIC-LY10
Record last reviewed:  July 2003
Last Updated:  October 13, 2004
Record first received:  April 10, 2001
ClinicalTrials.gov Identifier:  NCT00014209
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08