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Gemcitabine, Carboplatin, and Dexamethasone With or Without Rituximab in Treating Patients With Relapsed or Primary Refractory Lymphoma

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: University of Washington
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00072514
  Purpose

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and dexamethasone, use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, carboplatin, and dexamethasone with or without rituximab in treating patients who have relapsed or primary refractory lymphoma.


Condition Intervention Phase
Lymphoma
Drug: carboplatin
Drug: dexamethasone
Drug: gemcitabine hydrochloride
Drug: rituximab
Phase II

MedlinePlus related topics:   Cancer    Lymphoma   

Drug Information available for:   Carboplatin    Dexamethasone    Dexamethasone acetate    Dexamethasone Sodium Phosphate    Doxiproct plus    Gemcitabine hydrochloride    Gemcitabine    Rituximab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Study Evaluating the Efficacy of Gemcitabine, Carboplatin, Dexamethasone and Rituximab for Previously Treated Lymphoid Malignancies

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate after 2-4 courses [ Designated as safety issue: No ]

Estimated Enrollment:   51
Study Start Date:   December 2001
Estimated Primary Completion Date:   April 2013 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Stratum I (CD20 negative): Experimental
Patients receive carboplatin IV over 30 minutes on day 1; gemcitabine IV over 30 minutes on days 1 and 8; and oral dexamethasone on days 1-4.
Drug: carboplatin
Given IV
Drug: dexamethasone
Given orally
Drug: gemcitabine hydrochloride
Given IV
Stratum II (CD20 positive): Experimental
Patients receive carboplatin, gemcitabine, and dexamethasone as in stratum I and rituximab IV on day 8.
Drug: carboplatin
Given IV
Drug: dexamethasone
Given orally
Drug: gemcitabine hydrochloride
Given IV
Drug: rituximab
Given IV

Detailed Description:

OBJECTIVES:

  • Determine the feasibility and safety of gemcitabine, carboplatin, and dexamethasone with or without rituximab, in terms of response rate, in patients with relapsed or primary refractory lymphoid malignancy.
  • Determine the efficacy of these regimens in these patients.
  • Determine the impact of these regimens on stem cell reserve in these patients.
  • Determine the remission duration in patients treated with these regimens.

OUTLINE: This is a pilot study. Patients are stratified according to CD20 expression (negative vs positive).

  • Stratum I (CD20 negative): Patients receive carboplatin IV over 30 minutes on day 1; gemcitabine IV over 30 minutes on days 1 and 8; and oral dexamethasone on days 1-4.
  • Stratum II (CD20 positive): Patients receive carboplatin, gemcitabine, and dexamethasone as in stratum I and rituximab IV on day 8.

In both strata, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 5 years.

PROJECTED ACCRUAL: Approximately 51 patients will be accrued for this study within 2-3 years.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of relapsed or primary refractory lymphoid malignancy, with REAL or WHO classification provided, including the following types:

    • B-cell lymphoma
    • T-cell lymphoma
    • Hodgkin's lymphoma
  • No disease refractory (i.e., not responded or progressed within 6 months) to a carboplatin- or cisplatin-based regimen or a gemcitabine-based regimen
  • Bidimensionally measurable disease by CT chest/abdomen/pelvis within 28 days of enrollment

    • At least 1 cm by CT scan, MRI, medical photograph (skin or oral lesion), plain x-ray, or other conventional techniques OR at least 2 cm by palpation
  • Bone marrow aspirate and biopsy within the past 28 days

    • No prior anticancer therapy during the interval between bone marrow aspirate and biopsy and study entry
  • No active CNS lymphoma

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • SWOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Patients with cytopenia due to disease in bone marrow that do not meet these criteria may be enrolled at the Study Chair's discretion

Hepatic

  • Bilirubin less than 2 times upper limit of normal (ULN)
  • No active HBV infection or hepatitis

Renal

  • Creatinine less than 1.5 times ULN
  • Creatine clearance greater than 50 mL/min

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 6 months after study participation
  • HIV negative
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No other medical condition that would preclude study treatment
  • Must be anticipated to complete at least 2 courses of therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072514

Locations
United States, Washington
Seattle Cancer Care Alliance    
      Seattle, Washington, United States, 98109-1023

Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)

Investigators
Study Chair:     Ajay K. Gopal, MD     Seattle Cancer Care Alliance    
Investigator:     John Pagel, MD, PhD     Fred Hutchinson Cancer Research Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Seattle Cancer Care Alliance ( Ajay K. Gopal )
Study ID Numbers:   CDR0000339814, UW-LYM.03.01, PSOC-2003, LILLY-B9E-US-X348
First Received:   November 4, 2003
Last Updated:   November 11, 2008
ClinicalTrials.gov Identifier:   NCT00072514
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult diffuse large cell lymphoma  
recurrent adult diffuse mixed cell lymphoma  
recurrent adult diffuse small cleaved cell lymphoma  
recurrent adult Burkitt lymphoma  
recurrent adult Hodgkin lymphoma  
recurrent adult immunoblastic large cell lymphoma  
recurrent adult lymphoblastic lymphoma  
recurrent adult T-cell leukemia/lymphoma  
recurrent cutaneous T-cell non-Hodgkin lymphoma  
recurrent grade 1 follicular lymphoma  
recurrent grade 2 follicular lymphoma  
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
anaplastic large cell lymphoma
intraocular lymphoma
recurrent mycosis fungoides/Sezary syndrome
angioimmunoblastic T-cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Study placed in the following topic categories:
Dexamethasone
Sezary syndrome
Hodgkin's disease
Hodgkin lymphoma, adult
Cutaneous T-cell lymphoma
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Sezary Syndrome
Lymphoma, B-Cell, Marginal Zone
Mycosis Fungoides
Lymphoma, large-cell, immunoblastic
Lymphoma, large-cell
Lymphoma, B-Cell
Burkitt's lymphoma
Leukemia
Mycoses
Lymphoma, T-Cell
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Large-Cell, Anaplastic
Gemcitabine
Hodgkin Disease
Lymphoma
Dexamethasone acetate
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Rituximab
Leukemia, B-cell, chronic
Leukemia-Lymphoma, Adult T-Cell
Carboplatin

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Therapeutic Uses
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Enzyme Inhibitors
Glucocorticoids
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Autonomic Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2008




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