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| ID | Type | Description | Link |
|---|---|---|---|
| SCCC-2007092 |
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RATIONALE: 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 cell-killing substances to them. Drugs used in chemotherapy, such as gemcitabine and vinorelbine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with gemcitabine and vinorelbine may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with gemcitabine and vinorelbine works in treating patients with Hodgkin lymphoma that has relapsed or not responded to treatment.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are assigned to 1 of 2 treatment groups according to eligibility for stem cell transplantation (SCT).
After completion of study therapy, patients are followed for at least 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (eligible for SCT) | Experimental | Patients receive rituximab IV, vinorelbine ditartrate IV over 6-10 minutes, and gemcitabine hydrochloride IV over 30 minutes on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response (PR) undergo SCT. |
|
| Group 2 (ineligible for SCT) | Experimental | Patients receive rituximab, vinorelbine ditartrate, gemcitabine hydrochloride, and pegfilgrastim as in group 1. Patients with CR, PR, or stable disease after 3 courses continue to receive therapy in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate (complete response, unconfirmed complete response, partial response) | After first 3 cycles of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival, failure-free survival, and overall survival | Treatment start date to date of death for any reason | |
| Safety profile | Cycle 1 Day 1 through Follow-up | |
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DISEASE CHARACTERISTICS:
Pathologically confirmed classical Hodgkin lymphoma, including 1 of the following cell types:
Measurable disease using the Cheson criteria, defined as ≥ 1 unidimensionally measurable lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
Progressive or relapsed disease after ≥ 1 prior line of combination chemotherapy
No known CNS metastasis
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
ANC > 1,500/mm^3
Platelet count > 75,000/mm^3
Total bilirubin ≤ 2 mg/dL (unless due to hemolysis)
AST or ALT ≤ 2.5 times upper limit of normal
Creatinine normal OR creatinine clearance ≥ 50 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No active hepatitis B infection
No known chronic hepatitis B carrier
No HIV positivity
No concurrent uncontrolled illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra Stefanovic, MD | University of Miami Sylvester Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida | 33136 | United States |
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| gemcitabine hydrochloride | Drug | Given IV |
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| vinorelbine ditartrate | Drug | Given IV |
|
| Rate of adequate stem cell collection |
This will be assessed only for patients eligible for stem-cell transplantation after completion of R-Gemzar/Navelbine therapy |
| After completion of 3 cycle of treatment |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D000093542 | Gemcitabine |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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