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

NCT ID: NCT00014209

Last Updated: 2020-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-12-12
• Study Completion Date: 2009-02-10

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

cisplatin

Intervention Type: DRUG

dexamethasone

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

NCIC Clinical Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael R. Crump, MD, FRCPC

Role: STUDY_CHAIR

Princess Margaret Hospital, Canada

Locations

Tom Baker Cancer Center - Calgary

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

Moncton Hospital

Moncton, New Brunswick, Canada

Newfoundland Cancer Treatment and Research Foundation

St. John's, Newfoundland and Labrador, Canada

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, Canada

Kingston Regional Cancer Centre

Kingston, Ontario, Canada

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, Canada

Credit Valley Hospital

Mississauga, Ontario, Canada

Northwestern Ontario Regional Cancer Centre, Thunder Bay

Thunder Bay, Ontario, Canada

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Humber River Regional Hospital

Weston, Ontario, Canada

Cancer Care Ontario - Windsor Regional Cancer Centre

Windsor, Ontario, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 15386331 (View on PubMed)

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.

Reference Type: RESULT

PMID: 14630682 (View on PubMed)

Other Identifiers

LILLY-CAN-NCIC-LY10

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000068518

Identifier Type: OTHER

Identifier Source: secondary_id

LY10

Identifier Type: -

Identifier Source: org_study_id