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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
cisplatin
dexamethasone
gemcitabine hydrochloride
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring recurrent adult Hodgkin lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, anaplastic large cell lymphoma

Eligibility Criteria

16 Years - 120 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 1 prior chemotherapy regimen (excluding gemcitabine and cisplatin) No known CNS involvement NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. 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/mm^3 Platelet count at least 100,000/mm^3 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 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

Sites / Locations

  • Tom Baker Cancer Center - Calgary
  • Cross Cancer Institute
  • Moncton Hospital
  • Newfoundland Cancer Treatment and Research Foundation
  • Cancer Care Ontario-Hamilton Regional Cancer Centre
  • Kingston Regional Cancer Centre
  • Cancer Care Ontario-London Regional Cancer Centre
  • Credit Valley Hospital
  • Northwestern Ontario Regional Cancer Centre, Thunder Bay
  • Toronto Sunnybrook Regional Cancer Centre
  • Princess Margaret Hospital
  • Humber River Regional Hospital
  • Cancer Care Ontario - Windsor Regional Cancer Centre

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 10, 2001
Last Updated
April 7, 2020
Sponsor
NCIC Clinical Trials Group
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00014209
Brief Title
Combination Chemotherapy in Hodgkin's Disease or Non-Hodgkin's Lymphoma Not Responding to Previous Treatment
Official Title
A Phase II Study Of Gemcitabine, Dexamethasone, And Cisplatin (GDP) In Patients With Either Hodgkin's Disease Or Aggressive Histology Non-Hodgkin's Lymphoma Which Is Relapsed Or Refractory
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 12, 2000 (Actual)
Primary Completion Date
July 15, 2002 (Actual)
Study Completion Date
February 10, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group
Collaborators
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
recurrent adult Hodgkin lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, anaplastic large cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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 1 prior chemotherapy regimen (excluding gemcitabine and cisplatin) No known CNS involvement NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. 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/mm^3 Platelet count at least 100,000/mm^3 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael R. Crump, MD, FRCPC
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Study Chair
Facility Information:
Facility Name
Tom Baker Cancer Center - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Moncton Hospital
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6ZB
Country
Canada
Facility Name
Newfoundland Cancer Treatment and Research Foundation
City
St. Johns
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Cancer Care Ontario-Hamilton Regional Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Kingston Regional Cancer Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
Cancer Care Ontario-London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Credit Valley Hospital
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2N1
Country
Canada
Facility Name
Northwestern Ontario Regional Cancer Centre, Thunder Bay
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7A 7T1
Country
Canada
Facility Name
Toronto Sunnybrook Regional Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Humber River Regional Hospital
City
Weston
State/Province
Ontario
ZIP/Postal Code
M9N 1N8
Country
Canada
Facility Name
Cancer Care Ontario - Windsor Regional Cancer Centre
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 2X3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15386331
Citation
Crump M, Baetz T, Couban S, Belch A, Marcellus D, Howson-Jan K, Imrie K, Myers R, Adams G, Ding K, Paul N, Shepherd L, Iglesias J, Meyer R. Gemcitabine, dexamethasone, and cisplatin in patients with recurrent or refractory aggressive histology B-cell non-Hodgkin lymphoma: a Phase II study by the National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG). Cancer. 2004 Oct 15;101(8):1835-42. doi: 10.1002/cncr.20587.
Results Reference
result
PubMed Identifier
14630682
Citation
Baetz T, Belch A, Couban S, Imrie K, Yau J, Myers R, Ding K, Paul N, Shepherd L, Iglesias J, Meyer R, Crump M. Gemcitabine, dexamethasone and cisplatin is an active and non-toxic chemotherapy regimen in relapsed or refractory Hodgkin's disease: a phase II study by the National Cancer Institute of Canada Clinical Trials Group. Ann Oncol. 2003 Dec;14(12):1762-7. doi: 10.1093/annonc/mdg496.
Results Reference
result

Learn more about this trial

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

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