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Combination Chemotherapy Plus Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00005601
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 7, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:

RATIONALE: Drugs used in chemotherapy 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 combination chemotherapy with monoclonal antibody therapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus rituximab in treating patients who have relapsed non-Hodgkin's lymphoma.


Condition or disease Intervention/treatment Phase
Lymphoma Biological: rituximab Drug: cisplatin Drug: cytarabine Drug: dexamethasone Drug: sargramostim Phase 2

Detailed Description:

OBJECTIVES:

  • Determine response rate to cisplatin, cytarabine, and dexamethasone (DHAP) plus rituximab in patients with relapsed CD20+ B-cell non-Hodgkin's lymphoma.
  • Determine the percentage of patients able to proceed to transplant after two courses of this treatment regimen.
  • Determine the duration of response and overall survival of the patients not proceeding to transplant after two courses of this treatment regimen.

OUTLINE: Patients receive rituximab IV on days 1, 8, 15, and 22 for the first course only. Patients receive dexamethasone orally or IV on days 1-4, cisplatin IV continuously for 24 hours on day 1, cytarabine IV over 3 hours every 12 hours for 2 doses on day 2, and sargramostim (GM-CSF) subcutaneously on days 3-12 or until blood counts recover. Chemotherapy repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 17-50 patients will be accrued for this study within 11 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Cisplatinum, Cytosine Arabinoside, Dexamethasone (DHAP) With Rituxan in Patients With Relapsed CD20+ B-Cell Non-Hodgkin's Lymphoma
Study Start Date : October 2000
Actual Primary Completion Date : July 2003
Actual Study Completion Date : February 2008


Arm Intervention/treatment
Experimental: rituximab+dexamethasone+cisplatin+cytarabine+sargramostim

Patients receive rituximab IV on days 1, 8, 15, and 22 for the first course only. Patients receive dexamethasone orally or IV on days 1-4, cisplatin IV continuously for 24 hours on day 1, cytarabine IV over 3 hours every 12 hours for 2 doses on day 2, and sargramostim (GM-CSF) subcutaneously on days 3-12 or until blood counts recover. Chemotherapy repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

Biological: rituximab
Drug: cisplatin
Drug: cytarabine
Drug: dexamethasone
Drug: sargramostim



Primary Outcome Measures :
  1. response [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. percentage of patients able to proceed to transplant after two courses of this treatment regimen [ Time Frame: Up to 5 years ]
  2. duration of response [ Time Frame: Up to 5 years ]
  3. overall survival [ Time Frame: Up to 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed CD20+ B-cell non-Hodgkin's lymphoma

    • Relapsed following chemotherapy and eligible for platinum-containing regimen
  • Measurable disease

    • Must be at least 1.5 x 1.5 cm

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 75,000/mm^3

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL

Renal:

  • Creatinine no greater than 1.5 times upper limit of normal

Cardiovascular:

  • No uncontrolled hypertension

Other:

  • HIV negative
  • No other active malignancy
  • No uncontrolled diabetes mellitus
  • No uncontrolled peptic ulcer disease
  • No uncontrolled infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005601


Locations
Show Show 21 study locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Thomas E. Witzig, MD Mayo Clinic
Publications of Results:
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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00005601    
Other Study ID Numbers: NCCTG-N9981
NCI-2012-02326 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000067714 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Keywords provided by Alliance for Clinical Trials in Oncology:
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
recurrent mantle 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
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Dexamethasone
Rituximab
Sargramostim
Antineoplastic Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Immunological
Immunologic Factors
Antirheumatic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents