Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma
Overview[ - collapse ][ - ]
| Purpose | 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 cancer-killing substances to them. Drugs used in chemotherapy 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 combination chemotherapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective when given with rituximab in treating mantle cell lymphoma. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with previously untreated mantle cell lymphoma. |
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| Condition | Lymphoma |
| Intervention | Biological: G-CSF Drug: Rituximab Drug: Cyclophosphamide Drug: Cytarabine Drug: Doxorubicin Drug: Etoposide Drug: Ifosfamide Drug: Leucovorin Drug: Mesna Drug: Methotrexate Drug: Vincristine |
| Phase | Phase 2 |
| Sponsor | University of Miami Sylvester Comprehensive Cancer Center |
| Responsible Party | University of Miami Sylvester Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier | NCT00878254 |
| First Received | April 7, 2009 |
| Last Updated | February 28, 2014 |
| Last verified | February 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 7, 2009 |
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| Last Updated Date | February 28, 2014 |
| Start Date | March 2009 |
| Estimated Primary Completion Date | December 2017 |
| Current Primary Outcome Measures | Progression-free survival [Time Frame: 8 years] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma |
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| Official Title | Phase II Study of Rituximab in Combination With Methotrexate, Doxorubicin, Cyclophosphamide, Leucovorin, Vincritine, Ifosfamide, Etoposide, Cytarabine and Mesna (R-MACLO/VAM) in Patients With Previously Untreaded Mantle Cell Lymphoma |
| Brief Summary | 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 cancer-killing substances to them. Drugs used in chemotherapy 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 combination chemotherapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective when given with rituximab in treating mantle cell lymphoma. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with previously untreated mantle cell lymphoma. |
| Detailed Description | OBJECTIVES: Primary - To evaluate progression-free survival of patients with previously untreated mantle cell lymphoma treated with rituximab and combination chemotherapy comprising methotrexate, doxorubicin hydrochloride, cyclophosphamide, leucovorin calcium, vincristine sulfate, ifosfamide, etoposide, and cytarabine. Secondary - To evaluate overall survival of patients treated with this regimen. - To evaluate the response rate in patients treated with this regimen. - To evaluate the toxicity of this regimen in these patients. OUTLINE: - Courses 1 and 3: Patients receive rituximab IV and doxorubicin hydrochloride IV on day 1; vincristine sulfate IV on days 1 and 8; cyclophosphamide IV over 30 minutes on days 1-5; methotrexate IV continuously over 24 hours on day 10; leucovorin calcium IV every 6 hours beginning beginning 36 hours after start of methotrexate infusion and continuing until methotrexate level is below 0.05 nM; and filgrastim (G-CSF) subcutaneously (SC) beginning on day 13 and continuing until blood counts recover. - Courses 2 and 4: Patients receive rituximab IV on day 1; cytarabine IV over 3 hours every 12 hours on days 1 and 2; ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5; and G-CSF SC beginning on day 7 and continuing until blood counts recover. Patients who achieve complete remission after completion of course 4 receive rituximab IV once weekly for 4 weeks. Treatment repeats every 6 months for up to 3 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed monthly for 3 months, every 3 months for 2 years, every 6 months for 3-5 years, and then yearly thereafter. |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Lymphoma |
| Intervention | Biological: G-CSF G-CSF 480 mcg SQ starting on day 12 (Cycle 1), day 7 (Cycle 2), day 13 (Cycle 3), day 7 (Cycle 4) Other Names:
375 mg/m2 IV according to standard protocol; Day 1 for 4 Cycles Other Names: RituxanDrug: Cyclophosphamide Cyclophosphamide 800 mg/m2 IV, Day 1 - for 4 Cycles and 200 mg/m2 IV, Days 2 - 5 for 4 Cycles Other Names: CytoxanDrug: Cytarabine Cytarabine 2 grams/m2 IV every 12 hours x 4 doses, days 1 and 2, Cycles 2 and 4 Other Names: AraCDrug: Doxorubicin Doxorubicin 45 mg/m2 IV bolus Day 1 , Cycles 1 and 3 Other Names: AdriamycinDrug: Etoposide Etoposide 60 mg/m2 IV daily x 5 days, Days 1 - 5, Cycles 2 and 4 Other Names: VP16Drug: Ifosfamide Ifosfamide 1.5 grams/m2 IV QD x 5 days, Days 1 - 5, Cycles 2 and 4 Other Names: IfexDrug: Leucovorin Leucovorin 100 mg/m2 IV beginning 36 hours after start of methotrexate infusion and then 10 mg/m2 IV every 6 hours until methotrexate level is below 0.05 nM. Day 10, Cycles 1 and 3. Other Names: Folinic acidDrug: Mesna Mesna 360 mg/m2 IV every 3 hours x 5 days, Days 1 - 5 Cycles 2 and 4 Other Names: MesnexDrug: Methotrexate Methotrexate 1,200 mg/m2 in 250 mL D5W IV over 1 hour followed by Methotrexate 3,000 mg/m2 in 1,000 mL D5W by continuous infusion over 23 hours (130 mg/m2 every hour for 23 hours). Day 10 Cycles 1 and 3 Drug: Vincristine Vincristine 1.5 mg/m2 IVP (maximum of 2 mg) days 1 and 8 for Cycles 1 and 3 Other Names: Oncovin |
| Study Arm (s) | Experimental: R-MACLO/IVAM |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 22 |
| Estimated Completion Date | December 2017 |
| Estimated Primary Completion Date | December 2017 |
| Eligibility Criteria | DISEASE CHARACTERISTICS: - Histologically confirmed mantle cell lymphoma - Previously untreated disease - Measurable or evaluable disease - No CNS involvement PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Life expectancy > 6 months - Bilirubin < 3 mg/dL - SGOT and SGPT < 2.5 times upper limit of normal (unless due to lymphomatous involvement) - Serum creatinine < 1.5 mg/dL - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No grade 3-4 cardiac failure - LVEF ≥ 50% - No known history of HIV or AIDS - No hepatitis or hepatitis B virus infection - No other concurrent active malignancy, except carcinoma in situ of the cervix and basal cell carcinoma of the skin - No psychological, familial, sociological, or geographical conditions that would prohibit treatment and/or medical follow-up required to comply with study protocol PRIOR CONCURRENT THERAPY: - No prior chemotherapy, immunotherapy, or radiotherapy for this lymphoma |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00878254 |
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| Other Study ID Numbers | UMIAMI-20080803 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | University of Miami Sylvester Comprehensive Cancer Center |
| Study Sponsor | University of Miami Sylvester Comprehensive Cancer Center |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Izidore S. Lossos, MD University of Miami Sylvester Comprehensive Cancer Center |
| Verification Date | February 2014 |
Locations[ + expand ][ + ]
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami, Florida, United States, 33186 Contact: Izidore S. Lossos, MD | 866-574-5124Recruiting |
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