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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT00072514
Phase
PHASE2
Status
Completed

Conditions

  • 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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • gemcitabine hydrochloride — DRUG
    Given IV
  • carboplatin — DRUG
    Given IV
  • dexamethasone — DRUG
    Given PO
  • rituximab — BIOLOGICAL
    Given IV in CD20-POSITIVE LYMPHOMAS cases

Study Details

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

Key Dates

Start date
Aug 31, 2003
Status verified
May 2017
Primary completion
Jul 31, 2008
Completion
Nov 30, 2013

Study Design

Enrollment
55 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    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. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.

Primary Outcome Measure

Ability to Successfully Deliver the Investigational Therapy Without Incurring the Protocol Suspension Rules [ Time Frame: At 3-4 weeks after completion of study treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattleWashington98109-

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By research site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium· Seattle, WA

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