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A Phase II Study Evaluating the Efficacy of Gemcitabine, Carboplatin, and Dexamethasone and Rituximab for Previously Treated Lymphoid Malignancies


Phase 2
18 Years
N/A
Open (Enrolling)
Both
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

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Trial Information

A Phase II Study Evaluating the Efficacy of Gemcitabine, Carboplatin, and Dexamethasone and Rituximab for Previously Treated Lymphoid Malignancies


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Ability to successfully deliver the investigational therapy without incurring the protocol suspension rules

Outcome Time Frame:

At 3-4 weeks after completion of study treatment

Safety Issue:

No

Principal Investigator

Ajay Gopal

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Federal Government

Study ID:

PSOC 2003

NCT ID:

NCT00072514

Start Date:

August 2003

Completion Date:

Related Keywords:

  • 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
  • Waldenström Macroglobulinemia
  • Burkitt Lymphoma
  • Hodgkin Disease
  • Immunoblastic Lymphadenopathy
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphomatoid Granulomatosis
  • Waldenstrom Macroglobulinemia
  • Mycoses
  • Mycosis Fungoides
  • Sezary Syndrome
  • Lymphoma, B-Cell
  • 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

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109