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Combination Chemotherapy in Hodgkin's Disease or Non-Hodgkin's Lymphoma Not Responding to Previous Treatment

Phase 2
Completed
Conditions
Lymphoma
Registration Number
NCT00014209
Lead Sponsor
NCIC Clinical Trials Group
Brief Summary

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.

Detailed Description

OBJECTIVES:

* Determine the efficacy of gemcitabine, dexamethasone, and cisplatin in patients with relapsed or refractory Hodgkin's disease or aggressive non-Hodgkin's lymphoma.

* Determine the qualitative and quantitative toxicity of this regimen in these two patient populations.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
77
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (13)

Credit Valley Hospital

🇨🇦

Mississauga, Ontario, Canada

Cancer Care Ontario-Hamilton Regional Cancer Centre

🇨🇦

Hamilton, Ontario, Canada

Princess Margaret Hospital

🇨🇦

Toronto, Ontario, Canada

Northwestern Ontario Regional Cancer Centre, Thunder Bay

🇨🇦

Thunder Bay, Ontario, Canada

Cancer Care Ontario-London Regional Cancer Centre

🇨🇦

London, Ontario, Canada

Moncton Hospital

🇨🇦

Moncton, New Brunswick, Canada

Newfoundland Cancer Treatment and Research Foundation

🇨🇦

St. Johns, Newfoundland and Labrador, Canada

Cancer Care Ontario - Windsor Regional Cancer Centre

🇨🇦

Windsor, Ontario, Canada

Toronto Sunnybrook Regional Cancer Centre

🇨🇦

Toronto, Ontario, Canada

Tom Baker Cancer Center - Calgary

🇨🇦

Calgary, Alberta, Canada

Cross Cancer Institute

🇨🇦

Edmonton, Alberta, Canada

Humber River Regional Hospital

🇨🇦

Weston, Ontario, Canada

Kingston Regional Cancer Centre

🇨🇦

Kingston, Ontario, Canada

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