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Combination Chemotherapy in Treating Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma That Has Not Responded to Previous Treatment
This study has been completed.
First Received: April 10, 2001   Last Updated: March 5, 2010   History of Changes
Sponsor: NCIC Clinical Trials Group
Information provided by: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00014209
  Purpose

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 Intervention Phase
Lymphoma
Drug: cisplatin
Drug: dexamethasone
Drug: gemcitabine hydrochloride
Phase II

Study Type: Interventional
Study Design: Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Study Start Date: December 2000
Study Completion Date: February 2009
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00014209

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

Additional Information:
Publications:
Study ID Numbers: CDR0000068518, CAN-NCIC-LY10, LILLY-CAN-NCIC-LY10
Study First Received: April 10, 2001
Last Updated: March 5, 2010
ClinicalTrials.gov Identifier: NCT00014209     History of Changes
Health Authority: United States: Federal Government

Keywords provided by NCIC Clinical Trials Group:
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

Additional relevant MeSH terms:
Antimetabolites
Anti-Inflammatory Agents
Dexamethasone
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Cisplatin
Therapeutic Uses
Gemcitabine
Lymphoma
Hodgkin Disease
Dexamethasone acetate
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Glucocorticoids
Pharmacologic Actions
Lymphatic Diseases
Neoplasms

ClinicalTrials.gov processed this record on March 21, 2010