Gemcitabine Hydrochloride, Carboplatin, Dexamethasone, and Rituximab in Treating Patients With Previously Treated Lymphoid Malignancies

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00072514
First received: November 4, 2003
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

This pilot phase II trial studies the side effects and how well giving gemcitabine hydrochloride, carboplatin, dexamethasone, and rituximab together works in treating patients with previously treated lymphoid malignancies. Drugs used in chemotherapy, such as gemcitabine hydrochloride, carboplatin, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving more than one drug (combination chemotherapy) and giving monoclonal antibody therapy with chemotherapy may kill more cancer cells


Condition Intervention Phase
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Cutaneous B-cell Non-Hodgkin Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Hepatosplenic T-cell Lymphoma
Intraocular Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Noncutaneous Extranodal Lymphoma
Peripheral T-cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
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
Recurrent Marginal Zone Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Small Intestine Lymphoma
Splenic Marginal Zone Lymphoma
Testicular Lymphoma
Waldenstrom Macroglobulinemia
Drug: gemcitabine hydrochloride
Drug: carboplatin
Drug: dexamethasone
Biological: rituximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Evaluating the Efficacy of Gemcitabine, Carboplatin, and Dexamethasone and Rituximab for Previously Treated Lymphoid Malignancies

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Ability to successfully deliver the investigational therapy without incurring the protocol suspension rules [ Time Frame: At 3-4 weeks after completion of study treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate compared to published response rates of patients treated with gemcitabine hydrochloride alone [ Time Frame: At baseline, day 1 of each course, and 3-4 weeks after completion of study treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: August 2003
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment

In Group 1 (CD20-NEGATIVE LYMPHOMAS), patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

In Group 2 (CD20-POSITIVE LYMPHOMAS), patients receive treatment as in group I. Patients also receive rituximab IV on day 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Drug: gemcitabine hydrochloride
Given IV
Other Names:
  • dFdC
  • difluorodeoxycytidine hydrochloride
  • gemcitabine
  • Gemzar
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Drug: dexamethasone
Given PO
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Biological: rituximab
Given IV in Group 2 only (CD20-POSITIVE LYMPHOMAS)
Other Names:
  • IDEC-C2B8
  • IDEC-C2B8 monoclonal antibody
  • Mabthera
  • MOAB IDEC-C2B8
  • Rituxan

Detailed Description:

OBJECTIVES:

I. To determine the feasibility and safety of Gemcitabine/Carboplatin/Dexamethasone with or without Rituximab in previously treated lymphoid malignancies (rituximab will only be evaluated in CD20 positive malignancies).

II. To determine the efficacy of the above regimen. III. To determine the ability to proceed to blood stem peripheral blood collection following the above regimens (the impact of above regimen on stem cell reserve).

IV. To determine remission duration.

OUTLINE: Patients are assigned to 1 of 2 treatment groups.

GROUP I: CD20-NEGATIVE LYMPHOMAS

GROUP II: CD20-POSITIVE LYMPHOMAS

After completion of study treatment, patients are followed up at 3-4 weeks and then every 6 months for 5 years.

  Eligibility

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

Inclusion Criteria:

  • Patients must have relapsed or primary refractory lymphoid malignancy (including B-cell, T-cell, or Hodgkin's Disease)
  • Revised European American classification (REAL), or World Health Organization (WHO) classification of patients malignancies must be provided
  • Patients must have measurable disease defined as lesions that can be accurately measured in two dimensions by computed tomography (CT), magnetic resonance imaging (MRI), medical photograph (skin or oral lesion), plain x-ray, or other conventional technique and a greatest transverse diameter of 1 cm or greater; or palpable lesions with both diameters >= 2 cm; Note: CT scans remain the standard for evaluation of nodal disease
  • Patients must have a bone marrow aspirate and biopsy within 28 days of enrollment and no intervening anticancer therapy
  • Patients must have a CT of chest, abdomen, and pelvis within 28 days of enrollment; patients with evidence of adenopathy in the neck must have a CT of neck
  • Patients should not have evidence active central nervous system lymphoma
  • Patients must have a Southwest Oncology Group (SWOG) performance status of 0, 1, or 2
  • Patients should have absolute neutrophil count (ANC) >= 1,500/uL; exception: patients with cytopenia thought to be due to disease in their bone marrow, that do not meet this criteria, may be enrolled on the protocol at the Study Chair's discretion
  • Patients should have platelets >= 100,000/uL; exception: patients with cytopenia thought to be due to disease in their bone marrow, that do not meet this criteria, may be enrolled on the protocol at the Study Chair's discretion
  • Serum bilirubin less than 2 times the upper limit of normal
  • Serum creatinine less than 1.5 times the upper limit of normal and creatinine clearance greater than 50/ mL per minute
  • Patients must have serum lactate dehydrogenase (LDH) performed within 14 days prior to treatment
  • All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
  • Must anticipate that patient will complete at least 2 cycles of chemotherapy

Exclusion Criteria:

  • Patients known to be human immunodeficiency virus (HIV) positive
  • Pregnant or nursing women; men or women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
  • Patients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, cervical cancer in situ, or other cancer from which the patient has been disease-free for 5 years or greater unless approved by the Principal Investigator (PI)
  • Patients that are refractory (i.e., not responded or progressed within 6 months) to a carboplatin or cisplatin-based regimen or a gemcitabine-based regimen
  • Patients with active hepatitis B virus (HBV) infection or hepatitis
  • Patients that have other medical conditions that would contraindicate treatment with aggressive chemotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Investigators
Principal Investigator: Ajay Gopal Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: Gopal, Ajay, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
ClinicalTrials.gov Identifier: NCT00072514     History of Changes
Other Study ID Numbers: PSOC 2003, NCI-2011-00035
Study First Received: November 4, 2003
Last Updated: November 25, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Burkitt Lymphoma
Hodgkin Disease
Immunoblastic Lymphadenopathy
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphomatoid Granulomatosis
Waldenstrom Macroglobulinemia
Mycoses
Mycosis Fungoides
Sezary Syndrome
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Large-Cell, Immunoblastic
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell, Peripheral
Lymphoma, Large-Cell, Anaplastic
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Extranodal NK-T-Cell
Lymphoma, Mantle-Cell
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 28, 2014